Trial Outcomes & Findings for Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (NCT NCT01474109)
NCT ID: NCT01474109
Last Updated: 2015-01-06
Results Overview
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
289 participants
Primary outcome timeframe
Baseline to week 16
Results posted on
2015-01-06
Participant Flow
Conducted at 70 centers in 17 countries. First patient randomized was 11 January 2012 and last patient, last visit was 29 November 2013.
A screening visit was performed between Day -14 and Day -1 of the study. Of the 327 patients screened for the study, 38 were screen failures.
Participant milestones
| Measure |
Macitentan 3mg
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Period 1: Baseline to Week 16
STARTED
|
95
|
97
|
97
|
|
Period 1: Baseline to Week 16
COMPLETED
|
88
|
91
|
95
|
|
Period 1: Baseline to Week 16
NOT COMPLETED
|
7
|
6
|
2
|
|
Period 2: Week 16 to End of Study
STARTED
|
88
|
91
|
95
|
|
Period 2: Week 16 to End of Study
COMPLETED
|
70
|
73
|
83
|
|
Period 2: Week 16 to End of Study
NOT COMPLETED
|
18
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Macitentan 3mg
n=95 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=97 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=97 Participants
matching placebo once daily
placebo: matching placebo once daily
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.10 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 12.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
86 participants
n=5 Participants
|
82 participants
n=7 Participants
|
88 participants
n=5 Participants
|
256 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
India
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
37 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 16Population: Full analysis set
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.
Outcome measures
| Measure |
Macitentan 3mg
n=95 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=97 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=97 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Incidence Rate of New Digital Ulcers (DUs) up to Week 16
|
0.9082 number of new DUs/observation days
|
0.9567 number of new DUs/observation days
|
0.8115 number of new DUs/observation days
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.
Outcome measures
| Measure |
Macitentan 3mg
n=92 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=92 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=94 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Percentage of Participants Without a New DU Up To Week 16
|
64.1 Percentage of participants
|
63.0 Percentage of participants
|
67.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 90 weeksPopulation: Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.
DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a \> 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.
Outcome measures
| Measure |
Macitentan 3mg
n=92 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=92 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=94 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Percentage of Participants With at Least One DU Complication
|
14.1 percentage of participants
|
19.6 percentage of participants
|
19.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).
Outcome measures
| Measure |
Macitentan 3mg
n=92 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=92 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=94 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16
Week 16
|
1.2 units on a scale
Standard Deviation 0.79
|
1.2 units on a scale
Standard Deviation 0.66
|
1.2 units on a scale
Standard Deviation 0.73
|
|
Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16
Baseline
|
1.3 units on a scale
Standard Deviation 0.73
|
1.4 units on a scale
Standard Deviation 0.70
|
1.3 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).
Outcome measures
| Measure |
Macitentan 3mg
n=92 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=92 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=94 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16
Baseline
|
1.1 units on a scale
Standard Deviation 0.71
|
1.2 units on a scale
Standard Deviation 0.66
|
1.1 units on a scale
Standard Deviation 0.62
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16
Week 16
|
1.1 units on a scale
Standard Deviation 0.73
|
1.1 units on a scale
Standard Deviation 0.64
|
1.1 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.
Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)
Outcome measures
| Measure |
Macitentan 3mg
n=92 Participants
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=92 Participants
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=94 Participants
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16
Baseline
|
3.0 units on a scale
Standard Deviation 1.15
|
3.0 units on a scale
Standard Deviation 1.09
|
3.0 units on a scale
Standard Deviation 1.09
|
|
Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16
Week 16
|
2.7 units on a scale
Standard Deviation 1.14
|
2.6 units on a scale
Standard Deviation 0.99
|
2.7 units on a scale
Standard Deviation 1.10
|
Adverse Events
Macitentan 3mg
Serious events: 17 serious events
Other events: 61 other events
Deaths: 0 deaths
Macitentan 10mg
Serious events: 14 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macitentan 3mg
n=94 participants at risk
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=97 participants at risk
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=97 participants at risk
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
3.1%
3/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
PNEUMONIA
|
2.1%
2/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
GANGRENE
|
3.2%
3/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
CELLULITIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
ERYSIPELAS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
SINUSITIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
PLEUROPERICARDITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
2.1%
2/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
MYOCARDIAL FIBROSIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Cardiac disorders
PERICARDITIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
3.2%
3/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
2.1%
2/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
3.1%
3/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Skin and subcutaneous tissue disorders
LEUKOCYTOCLASTIC VASCULITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Skin and subcutaneous tissue disorders
DRY GANGRENE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC SCLEROSIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
SCLERODERMA
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
General disorders
CHEST PAIN
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
General disorders
FATIGUE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
General disorders
PYREXIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Respiratory, thoracic and mediastinal disorders
HYDROTHORAX
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Injury, poisoning and procedural complications
FALL
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC BRONCHIAL CARCINOMA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Nervous system disorders
NEURALGIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Renal and urinary disorders
SCLERODERMA RENAL CRISIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Surgical and medical procedures
PROSTATIC OPERATION
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
GRANULOMATOSIS WITH POLYANGIITIS
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
HYPERTENSION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
HYPOTENSION
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
NECROSIS ISCHAEMIC
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
RAYNAUD'S PHENOMENON
|
1.1%
1/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Vascular disorders
EXTREMITY NECROSIS
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
0.00%
0/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
Other adverse events
| Measure |
Macitentan 3mg
n=94 participants at risk
macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily
|
Macitentan 10mg
n=97 participants at risk
macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily
|
Placebo
n=97 participants at risk
matching placebo once daily
placebo: matching placebo once daily
|
|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
14.9%
14/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
19.6%
19/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
12.4%
12/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
INFECTED SKIN ULCER
|
7.4%
7/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
12.4%
12/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
11.3%
11/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
General disorders
OEDEMA PERIPHERAL
|
7.4%
7/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
12.4%
12/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
6.2%
6/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
6.4%
6/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
8.2%
8/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
9.3%
9/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.3%
4/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
8.2%
8/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
7.2%
7/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.2%
3/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
7.2%
7/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
4.1%
4/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.1%
2/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
6.2%
6/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
6.2%
6/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.4%
6/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
7.2%
7/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Nervous system disorders
DIZZINESS
|
4.3%
4/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
2.1%
2/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.2%
3/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.2%
3/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
3.1%
3/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.4%
6/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
4.1%
4/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
7.2%
7/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Gastrointestinal disorders
NAUSEA
|
5.3%
5/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
4.1%
4/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
6.2%
6/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.3%
4/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
4.1%
4/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
6.2%
6/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
|
Infections and infestations
BRONCHITIS
|
7.4%
7/94 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
1.0%
1/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
5.2%
5/97 • From start of study treatment up to 30 days after treatment discontinuation, up to approximately 90 weeks
Safety analysis set. One patient was excluded in the safety analysis set as they did not receive study drug after randomisation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER