Trial Outcomes & Findings for Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout (NCT NCT01078389)

Last Updated: 2014-09-10

Results Overview

The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

314 participants

Primary outcome timeframe

Baseline and Month 24

Results posted on

2014-09-10

Participant Flow

Participants took part in the study at 65 investigative sites in the United States from 10 March 2010 to 3 September 2013.

Participants with a diagnosis of gout were enrolled equally in 1 of 2 treatment groups, once a day placebo or febuxostat 40 mg or 80 mg based on serum urate levels.

Participant milestones

Participant milestones
Measure	Febuxostat 40 mg or 80 mg Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Study STARTED	157	157
Overall Study COMPLETED	93	90
Overall Study NOT COMPLETED	64	67

Reasons for withdrawal

Reasons for withdrawal
Measure	Febuxostat 40 mg or 80 mg Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Overall Study Adverse Event	10	6
Overall Study Major Protocol Deviation	2	0
Overall Study Lost to Follow-up	23	23
Overall Study Voluntary Withdrawal	20	36
Overall Study Other	9	2

Baseline Characteristics

Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Febuxostat 40 mg or 80 mg n=157 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=157 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.	Total n=314 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 12.36 • n=5 Participants	50.1 years STANDARD_DEVIATION 11.72 • n=7 Participants	50.8 years STANDARD_DEVIATION 12.04 • n=5 Participants
Age, Customized <45 years	49 participants n=5 Participants	42 participants n=7 Participants	91 participants n=5 Participants
Age, Customized 45 to <65 years	85 participants n=5 Participants	99 participants n=7 Participants	184 participants n=5 Participants
Age, Customized ≥65 years	23 participants n=5 Participants	16 participants n=7 Participants	39 participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants	145 Participants n=7 Participants	288 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	119 participants n=5 Participants	121 participants n=7 Participants	240 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 participants n=5 Participants	36 participants n=7 Participants	62 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	131 participants n=5 Participants	121 participants n=7 Participants	252 participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	157 participants n=7 Participants	314 participants n=5 Participants
Height	176.3 cm STANDARD_DEVIATION 9.22 • n=5 Participants	176.5 cm STANDARD_DEVIATION 8.36 • n=7 Participants	176.4 cm STANDARD_DEVIATION 8.79 • n=5 Participants
Weight	102.8 kg STANDARD_DEVIATION 20.88 • n=5 Participants	100.7 kg STANDARD_DEVIATION 21.20 • n=7 Participants	101.7 kg STANDARD_DEVIATION 21.04 • n=5 Participants
Body Mass Index (BMI)	33.1 kg/m^2 STANDARD_DEVIATION 6.40 • n=5 Participants	32.3 kg/m^2 STANDARD_DEVIATION 6.23 • n=7 Participants	32.7 kg/m^2 STANDARD_DEVIATION 6.32 • n=5 Participants
BMI Categories <25 kg/m^2	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
BMI Categories 25 to <30 kg/m^2	37 participants n=5 Participants	46 participants n=7 Participants	83 participants n=5 Participants
BMI Categories ≥30 kg/m^2	109 participants n=5 Participants	100 participants n=7 Participants	209 participants n=5 Participants
Smoking History Never Smoked	84 participants n=5 Participants	94 participants n=7 Participants	178 participants n=5 Participants
Smoking History Current Smoker	32 participants n=5 Participants	25 participants n=7 Participants	57 participants n=5 Participants
Smoking History Ex-Smoker	41 participants n=5 Participants	38 participants n=7 Participants	79 participants n=5 Participants
Alcohol History Never Drank	37 participants n=5 Participants	35 participants n=7 Participants	72 participants n=5 Participants
Alcohol History Current Drinker	103 participants n=5 Participants	106 participants n=7 Participants	209 participants n=5 Participants
Alcohol History Ex-Drinker	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Renal History (Modification of Diet in Renal Disease [MDRD]) Moderately Impaired MDRD	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Renal History (Modification of Diet in Renal Disease [MDRD]) Mildly Impaired MDRD	105 participants n=5 Participants	115 participants n=7 Participants	220 participants n=5 Participants
Renal History (Modification of Diet in Renal Disease [MDRD]) Normal MDRD	49 participants n=5 Participants	40 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.

Outcome measures

Outcome measures
Measure	Febuxostat 40 mg or 80 mg n=86 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=82 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint Baseline	0.16 score on a scale Standard Deviation 0.444	0.11 score on a scale Standard Deviation 0.438
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint Change from Baseline at Month 24	0.01 score on a scale Standard Deviation 0.330	0.01 score on a scale Standard Deviation 0.248

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.

Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Febuxostat 40 mg or 80 mg n=91 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=86 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs Baseline	4.98 score on a scale Standard Deviation 9.707	4.56 score on a scale Standard Deviation 8.631
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs Change from Baseline at Month 24 (n=78,74)	0.31 score on a scale Standard Deviation 2.447	0.29 score on a scale Standard Deviation 1.746

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.

Outcome measures

Outcome measures
Measure	Febuxostat 40 mg or 80 mg n=91 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=86 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs Baseline	0.36 score on a scale Standard Deviation 1.160	0.17 score on a scale Standard Deviation 0.473
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs Change from Baseline at Month 24 (n=78,74)	0.17 score on a scale Standard Deviation 1.709	0.11 score on a scale Standard Deviation 0.969

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.

The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Febuxostat 40 mg or 80 mg n=157 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=157 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Edema (Distal+Proximal):Change from BL(n=77,66)	-0.36 score on a scale Standard Deviation 0.916	-0.10 score on a scale Standard Deviation 0.962
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Synovitis:Baseline (BL)(n=82,76)	1.29 score on a scale Standard Deviation 0.782	1.09 score on a scale Standard Deviation 0.687
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Synovitis:Change from Baseline (n=75,67)	-0.43 score on a scale Standard Deviation 0.713	-0.07 score on a scale Standard Deviation 0.531
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Erosion (Distal+Proximal):Baseline (n=84,77)	1.63 score on a scale Standard Deviation 0.935	1.48 score on a scale Standard Deviation 0.916
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Erosion (Distal+Proximal):Change from BL(n=79,69)	-0.01 score on a scale Standard Deviation 0.702	0.04 score on a scale Standard Deviation 0.475
Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint Edema (Distal+Proximal):Baseline (BL) (n=81,75)	0.73 score on a scale Standard Deviation 1.022	0.51 score on a scale Standard Deviation 0.919

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.

The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Febuxostat 40 mg or 80 mg n=86 Participants Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=82 Participants Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint Change from Baseline at Month 24(n=81,76)	0.00 score on a scale Standard Deviation 0.602	0.05 score on a scale Standard Deviation 0.361
Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint Baseline	0.85 score on a scale Standard Deviation 1.057	0.77 score on a scale Standard Deviation 1.022

Adverse Events

Febuxostat 40 mg or 80 mg

Serious events: 13 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo

Serious events: 11 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Febuxostat 40 mg or 80 mg n=157 participants at risk Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.	Placebo n=157 participants at risk Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Gastrointestinal disorders Diarrhoea	5.7% 9/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	5.1% 8/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 5/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	9.6% 15/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.2% 16/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	7.0% 11/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatine phosphokinase increased	5.7% 9/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.0% 11/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	6.4% 10/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Gamma-glutamyltransferase increased	3.8% 6/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 9/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.9% 14/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 10/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 9/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 13/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.7% 9/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.5% 4/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 8/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	3.2% 5/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 10/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	5.1% 8/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 7/157 • Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER