Trial Outcomes & Findings for Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients (NCT NCT02333383)

NCT ID: NCT02333383

Last Updated: 2019-01-15

Results Overview

The baseline assessment was performed prior to the first dose of adalimumab. The presence of peripheral arthritis (arthritis affecting shoulders, elbows, wrists, hands, knees, ankles, feet), enthesitis (inflammation of the areas where ligaments or tendons insert into bone) and dactylitis (inflammation of finger and/or toe joints) was noted. Peripheral arthritis was defined as ≥1 swollen joint on the Swollen Joint Count scale (SJC; range, 0 to 44, excluding hip joints). Enthesitis was defined as at least one inflamed enthesis in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0 to 13, with higher scores representing more severe disease) or of the plantar fascia of the foot. Dactylitis was measured by a simple count of dactylitic digits.

• Recruitment status: COMPLETED
• Target enrollment: 201 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-01-15

Participant Flow

Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline

Participant milestones

Measure	Participants With Ankylosing Spondylitis Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Study STARTED	201
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Measure	Participants With Ankylosing Spondylitis Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Study Adalimumab discontinuation	21
Overall Study Lost to Follow-up	15
Overall Study Withdrawal by Subject	3
Overall Study Transfer to another hospital	2

Baseline Characteristics

Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients

Baseline characteristics by cohort

Measure	Participants With Ankylosing Spondylitis n=201 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Age, Continuous	39.84 years STANDARD_DEVIATION 12.34 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	162 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	201 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline

The baseline assessment was performed prior to the first dose of adalimumab. The presence of peripheral arthritis (arthritis affecting shoulders, elbows, wrists, hands, knees, ankles, feet), enthesitis (inflammation of the areas where ligaments or tendons insert into bone) and dactylitis (inflammation of finger and/or toe joints) was noted. Peripheral arthritis was defined as ≥1 swollen joint on the Swollen Joint Count scale (SJC; range, 0 to 44, excluding hip joints). Enthesitis was defined as at least one inflamed enthesis in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0 to 13, with higher scores representing more severe disease) or of the plantar fascia of the foot. Dactylitis was measured by a simple count of dactylitic digits.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=201 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Frequency of Extra-Axial Manifestations (EAMs) of Interest Enthesitis	46.27 Percentage of participants Interval 39.23 to 53.42
Frequency of Extra-Axial Manifestations (EAMs) of Interest Peripheral arthritis	33.33 Percentage of participants Interval 26.86 to 40.31
Frequency of Extra-Axial Manifestations (EAMs) of Interest Dactylitis	2.99 Percentage of participants Interval 1.1 to 6.38

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline

The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI 50 is a 50% improvement from baseline in BASDAI score.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=189 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Week 12	142 Participants
Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Week 28	128 Participants
Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Week 36	142 Participants
Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Week 52	130 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had enthesitis at baseline

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=86 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline Week 12	-1.85 units on a scale Standard Deviation 2.50
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline Week 28	-2.31 units on a scale Standard Deviation 2.03
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline Week 36	-2.31 units on a scale Standard Deviation 1.78
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline Week 52	-2.50 units on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline

The plantar fascia is a ligament that runs along the bottom of each foot. The percentage of participants who had enthesitis of the plantar fascia was documented at each study visit.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=201 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Proportion of Participants With Enthesitis of the Plantar Fascia Week 28	2 Participants
Proportion of Participants With Enthesitis of the Plantar Fascia Week 36	4 Participants
Proportion of Participants With Enthesitis of the Plantar Fascia Week 52	7 Participants
Proportion of Participants With Enthesitis of the Plantar Fascia Baseline	19 Participants
Proportion of Participants With Enthesitis of the Plantar Fascia Week 12	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had dactylitis at baseline

Assessment of the presence or absence of dactylitis (inflammation of finger and/or toe joints) as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranged from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=6 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline Week 36	-5.00 units on a scale Standard Deviation 4.08
Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline Week 12	-3.83 units on a scale Standard Deviation 3.66
Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline Week 28	-4.40 units on a scale Standard Deviation 3.78
Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline Week 52	-5.00 units on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline

Forty-six joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 46 (worst possible score/46 joints with tenderness). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=67 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 12	-1.82 Tender joint counts Standard Deviation 3.43
Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 28	-2.05 Tender joint counts Standard Deviation 3.03
Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 36	-2.38 Tender joint counts Standard Deviation 3.13
Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 52	-2.60 Tender joint counts Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 28, Week 36, Week 52

Population: Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline

Forty-four joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 44 (worst possible score/44 joints with swelling). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=67 Participants Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 12	-1.80 Swollen joint counts Standard Deviation 2.25
Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 28	-1.98 Swollen joint counts Standard Deviation 2.79
Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 36	-2.04 Swollen joint counts Standard Deviation 2.86
Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline Week 52	-2.40 Swollen joint counts Standard Deviation 2.30

Adverse Events

Participants With Ankylosing Spondylitis

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With Ankylosing Spondylitis n=201 participants at risk Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Skin and subcutaneous tissue disorders Toxic skin eruption	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Cellulitis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pneumonia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Diarrhoea	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Pancreatitis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Pain	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders Lymphadenopathy	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Road traffic accident	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Measure	Participants With Ankylosing Spondylitis n=201 participants at risk Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Skin and subcutaneous tissue disorders Pruritus	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Rash	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Urticaria	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Cellulitis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Latent tuberculosis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pneumonia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	1.00% 2/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Diarrhoea	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Pancreatitis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Pain	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Pyrexia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders Lymphadenopathy	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Eye disorders Uveitis	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Road traffic accident	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations Alanine aminotransferase increased	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations Aspartate aminotransferase increased	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Vascular disorders Hypertension	0.50% 1/201 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

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