Trial Outcomes & Findings for Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis (NCT NCT03120949)
NCT ID: NCT03120949
Last Updated: 2023-10-12
Results Overview
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2106 participants
Primary outcome timeframe
up to Week 126
Results posted on
2023-10-12
Participant Flow
Enrollment was conducted at 241 sites in 18 countries (Argentina, Belarus, Bulgaria, Brazil, Colombia, Czech Republic, Germany, Estonia, United Kingdom, Hungary, South Korea, Lithuania, Latvia, Mexico, Poland, Russia, Taiwan, United States). A total of 2105 subjects who had previously completed 24 weeks of double-blind treatment in a core study were randomized. All except one randomized subject received OKZ treatment. A total of 2104 subjects were analyzed for efficacy in the mITT Population.
Participant milestones
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
Olokizumab 64 mg subcutaneous (SC) q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Overall Study
STARTED
|
1058
|
1047
|
|
Overall Study
mITT
|
1057
|
1047
|
|
Overall Study
Safety Population
|
1043
|
1061
|
|
Overall Study
COMPLETED
|
830
|
844
|
|
Overall Study
NOT COMPLETED
|
228
|
203
|
Reasons for withdrawal
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
Olokizumab 64 mg subcutaneous (SC) q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Overall Study
randomized in error
|
1
|
0
|
|
Overall Study
Death
|
13
|
13
|
|
Overall Study
Lost to Follow-up
|
23
|
13
|
|
Overall Study
Withdrawal by Subject
|
139
|
124
|
|
Overall Study
Covid-19
|
43
|
34
|
|
Overall Study
Patient Moved Out Of Residence And was Not Able To Come To The Site
|
1
|
3
|
|
Overall Study
Lack Of Discipline In Adhering To The Schedule Of Visits, Difficult Cooperation With The Patient
|
1
|
0
|
|
Overall Study
Safety Follow-Up Visit (SFU)-3 Was Performed By Phone Due To Family Reasons
|
1
|
0
|
|
Overall Study
Patient Completed The Treatment, But Could Not Come For Follow-Up Visits Due To Another City Moving
|
1
|
0
|
|
Overall Study
Site was closed
|
2
|
3
|
|
Overall Study
Study Coordinator Error, Patient Started A Biologic And Study Coordinator Forgot To Complete SFU
|
1
|
0
|
|
Overall Study
Principal Investigator (PI) Decision, The PI Starting Subject On Another Biologic Medication
|
0
|
1
|
|
Overall Study
PI Terminated Subject From IP (Ae's Abnormal Wbc, Abnormal Absolute Neutrophils Lab)
|
1
|
0
|
|
Overall Study
Patient Was Hospitalized Due To The SAE And Couldn't Visit The Site For Sfu-3
|
1
|
0
|
|
Overall Study
Other: Adverse Event
|
0
|
1
|
|
Overall Study
Due To The Death Of His Wife, He Refused To Participate In Follow Up 3
|
0
|
1
|
|
Overall Study
Follow Up Visit Not Performed (Patient Outside Residence)
|
0
|
2
|
|
Overall Study
Subject Refusal To Attend Visit
|
0
|
1
|
|
Overall Study
Personal Reasons
|
0
|
1
|
|
Overall Study
PI Did Not Feel It Was Best For Subject To Be Without Treatment For 12 Weeks.
|
0
|
1
|
|
Overall Study
Lack Of Efficacy (PI Perspective) End Of Study Visit
|
0
|
1
|
|
Overall Study
Compliance With Medication
|
0
|
1
|
|
Overall Study
Subject Has A Severe Or Life Threatening Infection That Requires Hospitalization Per Medical Monitor
|
0
|
1
|
|
Overall Study
Other: Protocol Violation (Refused From SFU Visits)
|
0
|
1
|
|
Overall Study
Study Terminated By Principal Investigator
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Total
n=2104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
914 Participants
n=5 Participants
|
896 Participants
n=7 Participants
|
1810 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
31 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
851 Participants
n=5 Participants
|
840 Participants
n=7 Participants
|
1691 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
357 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
689 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
700 Participants
n=5 Participants
|
715 Participants
n=7 Participants
|
1415 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
97 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
81 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
105 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
217 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
425 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
138 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
137 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
29 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.201 kg/m^2
n=5 Participants
|
28.229 kg/m^2
n=7 Participants
|
28.215 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Week 126Population: Safety Population
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations
|
401 Participants
|
408 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Nasopharyngitis
|
71 Participants
|
87 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Upper respiratory tract infection
|
59 Participants
|
67 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Bronchitis
|
59 Participants
|
45 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Investigations
|
284 Participants
|
290 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Investigations: Alanine aminotransferase increased
|
97 Participants
|
118 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Investigations: Aspartate aminotransferase increased
|
52 Participants
|
63 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders
|
149 Participants
|
152 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders
|
125 Participants
|
147 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders: Leukopenia
|
46 Participants
|
60 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders: Neutropenia
|
42 Participants
|
57 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Metabolism and nutrition disorders
|
113 Participants
|
135 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders
|
100 Participants
|
118 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications
|
101 Participants
|
95 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders
|
88 Participants
|
94 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders
|
60 Participants
|
81 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders
|
60 Participants
|
68 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders
|
60 Participants
|
68 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions
|
54 Participants
|
65 Participants
|
PRIMARY outcome
Timeframe: up to Week 126Population: Safety Population
Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Number of Subjects with at Least One SAE
|
129 Participants
|
120 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations
|
40 Participants
|
47 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Pneumonia
|
7 Participants
|
7 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Cellulitis
|
7 Participants
|
4 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Erysipelas
|
5 Participants
|
4 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: COVID-19
|
1 Participants
|
3 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Pyelonephritis acute
|
2 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: COVID-19 pneumonia
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Pyelonephritis
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Sepsis
|
0 Participants
|
3 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Abscess limb
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Diverticulitis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Osteomyelitis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Abdominal wall abscess
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Abscess soft tissue
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Acute sinusitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Atypical pneumonia
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Bartholinitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Bronchitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Bullous erysipelas
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Bursitis infective
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Cat scratch disease
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Dengue fever
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Device related infection
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Device related sepsis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Encephalomyelitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Gangrene
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Gastroenteritis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Influenza
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Intervertebral discitis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Joint abscess
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Latent tuberculosis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Localised infection
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Lower respiratory tract infection
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Ludwig angina
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Medical device site abscess
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Necrotising fasciitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Necrotising soft tissue infection
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Post procedural infection
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Pulmonary tuberculosis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Renal abscess
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Salpingo-oophoritis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Scrotal abscess
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Septic shock
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Streptococcal sepsis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Tonsillitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Urinary tract infection
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Viral infection
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Viral upper respiratory tract infection
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Infections and infestations: Wound infection pseudomonas
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders
|
14 Participants
|
11 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Osteoarthritis
|
6 Participants
|
6 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Osteonecrosis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Rheumatoid arthritis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Arthritis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Bursitis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Cervical spinal stenosis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Foot deformity
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Intervertebral disc protrusion
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Joint ankylosis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Muscle contracture
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Musculoskeletal chest pain
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal and connective tissue disorders: Spinal osteoarthritis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications
|
8 Participants
|
14 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Clavicle fracture
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Femoral neck fracture
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Head injury
|
2 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Hip fracture
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Acetabulum fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Arthropod bite
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Comminuted fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Concussion
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Extradural haematoma
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Femur fracture
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Foot fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Humerus fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Lower limb fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Multiple injuries
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Muscle rupture
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Overdose
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Post procedural complication
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Thoracic vertebral fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Traumatic intracranial haematoma
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications: Wrist fracture
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders
|
11 Participants
|
10 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Acute myocardial infarction
|
3 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Arrhythmia
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Atrial fibrillation
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Acute coronary syndrome
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Angina unstable
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Atrioventricular block complete
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Atrioventricular block second degree
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Bradycardia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Cardiac arrest
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Cardiac failure chronic
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Cardiac failure congestive
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Coronary artery occlusion
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Coronary artery stenosis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Myocardial infarction
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Right ventricular dysfunction
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Sinus tachycardia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Stress cardiomyopathy
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Supraventricular tachyarrhythmia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Cardiac disorders: Ventricular fibrillation
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders
|
8 Participants
|
12 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Diverticular perforation
|
1 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Abdominal pain
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Colitis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Gastritis erosive
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Abdominal hernia obstructive
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Dyspepsia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Gastric polyps
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Gastric ulcer
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Gastrointestinal disorder
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Intestinal obstruction
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Obstructive pancreatitis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Pancreatitis acute
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Pancreatitis chronic
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Peptic ulcer
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders: Salivary gland calculus
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
11 Participants
|
8 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Meningioma
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Benign neoplasm of thyroid gland
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Central nervous system neoplasm
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Cervix carcinoma stage II
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Clear cell renal cell carcinoma
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Colon cancer
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Endometrial adenocarcinoma
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Endometrial cancer
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Extranodal marginal zone B-cell lymphoma (MALT type)
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Gastric cancer
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Invasive ductal breast carcinoma
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Lung adenocarcinoma stage III
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Malignant melanoma
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Marginal zone lymphoma
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Meningioma benign
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Metastatic neoplasm
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Pancreatic carcinoma metastatic
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Salivary gland cancer
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Neoplasms benign, malignant and unspecified: Uterine leiomyoma
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders
|
13 Participants
|
6 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Cerebrovascular accident
|
4 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Dizziness
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Ischaemic stroke
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Syncope
|
2 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Carotid artery aneurysm
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Encephalopathy
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Migraine
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Myelopathy
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Paraesthesia
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Pineal gland cyst
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Seizure
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Subarachnoid haemorrhage
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders: Transient ischaemic attack
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders
|
7 Participants
|
12 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Pulmonary embolism
|
2 Participants
|
4 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Chronic obstructive pulmonary disease
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Pulmonary fibrosis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Respiratory failure
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Asthmatic crisis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Bronchitis chronic
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Chronic respiratory failure
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Chylothorax
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: effusion
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Pleurisy
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Respiratory, thoracic and mediastinal disorders: Pneumothorax
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Investigations
|
9 Participants
|
6 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Investigations: Alanine aminotransferase increased
|
7 Participants
|
5 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Investigations: Hepatic enzyme increased
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Investigations: Liver function test increased
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders
|
6 Participants
|
3 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Cholelithiasis
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Cholecystitis chronic
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Biliary colic
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Hepatotoxicity
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Hyperplastic cholecystopathy
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Hepatobiliary disorders: Liver injury
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions
|
4 Participants
|
4 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Death
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Sudden death
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Lithiasis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Pyrexia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Sudden cardiac death
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
General disorders and administration site conditions: Vascular stent occlusion
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders
|
3 Participants
|
3 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Uterine polyp
|
2 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Endometrial hyperplasia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Female genital tract fistula
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Genital haemorrhage
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Intermenstrual bleeding
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Reproductive system and breast disorders: Ovarian cyst
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders
|
4 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders: Dermatitis
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders: Skin ulcer
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders: Dermatitis contact
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders: Erythema
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders
|
4 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Deep vein thrombosis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Hypertensive crisis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Peripheral artery occlusion
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Shock haemorrhagic
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Thrombophlebitis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Vascular disorders: Varicose vein
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders
|
3 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders: Calculus urinary
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders: Nephritis
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders: Nephrolithiasis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders: Renal colic
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Renal and urinary disorders: Ureterolithiasis
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders
|
1 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders: Febrile neutropenia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders: Lymphadenopathy
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders: Splenic cyst
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Pregnancy, puerperium and perinatal conditions
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Pregnancy, puerperium and perinatal conditions: Abortion spontaneous
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Pregnancy, puerperium and perinatal conditions: Abortion threatened
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Pregnancy, puerperium and perinatal conditions: Ectopic pregnancy
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Ear and labyrinth disorders
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Ear and labyrinth disorders: Deafness neurosensory
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Ear and labyrinth disorders: Vestibular disorder
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Eye disorders
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Eye disorders: Cataract
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Eye disorders: Ocular myasthenia
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Immune system disorders
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Immune system disorders: Hypersensitivity
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Psychiatric disorders
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Psychiatric disorders: Completed suicide
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to Week 126Population: Safety Population
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Systemic Injection Reactions and Hypersensitivity Reactions
|
99 Participants
|
100 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Systemic Injection Reactions and Hypersensitivity Reactions: Anaphylactic Reactions
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Infections
|
389 Participants
|
398 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Infections: Opportunistic Infections
|
19 Participants
|
22 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Malignancies
|
9 Participants
|
6 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Basal cell carcinoma
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Elevation of Blood Lipids
|
120 Participants
|
138 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Gastrointestinal Perforations
|
1 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Neutropenia, Thrombocytopenia, Leukocytopenia and Pancytopenia
|
146 Participants
|
168 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Potential Hepatotoxicity
|
68 Participants
|
63 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Injection Site Reactions
|
34 Participants
|
34 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Demyelination in Peripheral or Central Nervous System
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Autoimmune Disorders
|
48 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: up to Week 126Population: Safety Population (3 Subjects discontinued treatment due to an AE but they did not have an AE that led to treatment discontinuation.)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
|
87 Participants
|
90 Participants
|
PRIMARY outcome
Timeframe: up to Week 126Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
|
48.75 subjects per 100 subject-years
|
49.84 subjects per 100 subject-years
|
PRIMARY outcome
Timeframe: up to Week 126Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
|
7.74 subjects per 100 subject-years
|
7.37 subjects per 100 subject-years
|
PRIMARY outcome
Timeframe: up to Week 126Population: An AE is defined as treatment-emergent under a given study treatment, if AE's onset date is on or after the date of first dose the corresponding treatment and prior to initiation of the next study treatment, if any.
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Incidence Rate of Treatment Emergent AESIs (Safety Population)
|
40.49 subjects per 100 subject-years
|
42.13 subjects per 100 subject-years
|
SECONDARY outcome
Timeframe: up to Week 82Population: mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study.
Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 12 OLE
|
861 Participants
|
863 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 20 OLE
|
850 Participants
|
851 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 28 OLE
|
839 Participants
|
829 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 40 OLE
|
795 Participants
|
795 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 52 OLE
|
780 Participants
|
783 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 64 OLE
|
777 Participants
|
774 Participants
|
|
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Week 82 OLE
|
811 Participants
|
830 Participants
|
SECONDARY outcome
Timeframe: up to Week 82Population: mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study.
Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 12 OLE
|
598 Participants
|
601 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 20 OLE
|
607 Participants
|
607 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 28 OLE
|
597 Participants
|
610 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 40 OLE
|
600 Participants
|
594 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 52 OLE
|
563 Participants
|
606 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 64 OLE
|
584 Participants
|
583 Participants
|
|
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Week 82 OLE
|
608 Participants
|
619 Participants
|
SECONDARY outcome
Timeframe: up to Week 82Population: mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study.
Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 12 OLE
|
330 Participants
|
362 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 20 OLE
|
358 Participants
|
353 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 28 OLE
|
367 Participants
|
357 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 40 OLE
|
375 Participants
|
369 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 52 OLE
|
370 Participants
|
387 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 64 OLE
|
373 Participants
|
387 Participants
|
|
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Week 82 OLE
|
382 Participants
|
393 Participants
|
SECONDARY outcome
Timeframe: up to week 82Population: Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment.
The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission). The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Core Baseline
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
OLE Baseline
|
137 Participants
|
145 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 12 OLE
|
161 Participants
|
190 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 20 OLE
|
192 Participants
|
197 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 28 OLE
|
196 Participants
|
196 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 40 OLE
|
204 Participants
|
211 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 52 OLE
|
218 Participants
|
225 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 64 OLE
|
223 Participants
|
257 Participants
|
|
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Week 82 OLE
|
231 Participants
|
267 Participants
|
SECONDARY outcome
Timeframe: up to Week 82Population: Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment.
Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) \< 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.36 × natural log (CRP+1)\] + \[0.014 × VAS\] + 0.96.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 52 OLE
|
679 Participants
|
680 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Core Baseline
|
1 Participants
|
1 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
OLE Baseline
|
573 Participants
|
537 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 12 OLE
|
681 Participants
|
685 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 20 OLE
|
703 Participants
|
714 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 28 OLE
|
684 Participants
|
694 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 40 OLE
|
688 Participants
|
691 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 64 OLE
|
681 Participants
|
678 Participants
|
|
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Week 82 OLE
|
706 Participants
|
712 Participants
|
SECONDARY outcome
Timeframe: Core baseline, Week 12Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
Week 12 OLE
|
1.03 score on a scale
Standard Deviation 0.632
|
1.00 score on a scale
Standard Deviation 0.628
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
Change from Core Baseline
|
-0.67 score on a scale
Standard Deviation 0.628
|
-0.74 score on a scale
Standard Deviation 0.648
|
SECONDARY outcome
Timeframe: Core baseline, Week 20Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
Week 20 OLE
|
1.00 score on a scale
Standard Deviation 0.647
|
0.99 score on a scale
Standard Deviation 0.621
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
Change from Core Baseline
|
-0.70 score on a scale
Standard Deviation 0.631
|
-0.74 score on a scale
Standard Deviation 0.640
|
SECONDARY outcome
Timeframe: Core baseline, Week 28Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
Week 28 OLE
|
0.99 score on a scale
Standard Deviation 0.632
|
0.99 score on a scale
Standard Deviation 0.627
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
Change from Core Baseline
|
-0.71 score on a scale
Standard Deviation 0.645
|
-0.75 score on a scale
Standard Deviation 0.652
|
SECONDARY outcome
Timeframe: Core baseline, Week 40Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
Week 40 OLE
|
0.97 score on a scale
Standard Deviation 0.651
|
0.99 score on a scale
Standard Deviation 0.635
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
Change from Core Baseline
|
-0.72 score on a scale
Standard Deviation 0.663
|
-0.75 score on a scale
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Core baseline, Week 52Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
Week 52 OLE
|
0.97 score on a scale
Standard Deviation 0.653
|
0.96 score on a scale
Standard Deviation 0.623
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
Change from Core Baseline
|
-0.72 score on a scale
Standard Deviation 0.670
|
-0.77 score on a scale
Standard Deviation 0.671
|
SECONDARY outcome
Timeframe: Core baseline, Week 64Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
Week 64 OLE
|
0.95 score on a scale
Standard Deviation 0.641
|
0.97 score on a scale
Standard Deviation 0.635
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
Change from Core Baseline
|
-0.74 score on a scale
Standard Deviation 0.643
|
-0.77 score on a scale
Standard Deviation 0.671
|
SECONDARY outcome
Timeframe: Core baseline, Week 82Population: mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits.
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
Core Baseline
|
1.70 score on a scale
Standard Deviation 0.581
|
1.74 score on a scale
Standard Deviation 0.561
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
Week 82 OLE
|
0.97 score on a scale
Standard Deviation 0.667
|
0.98 score on a scale
Standard Deviation 0.667
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
Change from Core Baseline
|
-0.72 score on a scale
Standard Deviation 0.680
|
-0.74 score on a scale
Standard Deviation 0.695
|
SECONDARY outcome
Timeframe: up to week 82Population: Intermediate missing data are imputed using surrounding visits. The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment.
The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline. HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 12 OLE
|
297 Participants
|
324 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 20 OLE
|
319 Participants
|
341 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 28 OLE
|
326 Participants
|
320 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 40 OLE
|
310 Participants
|
333 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 52 OLE
|
322 Participants
|
338 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 64 OLE
|
317 Participants
|
326 Participants
|
|
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Week 82 OLE
|
326 Participants
|
373 Participants
|
SECONDARY outcome
Timeframe: up to week 82Population: Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. Baseline is defined as the last available assessment prior to the first dose of the study treatment in the core study.
CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement. The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS)
Outcome measures
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1057 Participants
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1047 Participants
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 52
|
-31.35 index units
Standard Deviation 11.855
|
-31.60 index units
Standard Deviation 12.639
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 64 OLE Actual Values
|
8.42 index units
Standard Deviation 7.997
|
8.36 index units
Standard Deviation 7.798
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 64
|
-31.68 index units
Standard Deviation 11.896
|
-31.85 index units
Standard Deviation 12.484
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 82 OLE Actual Values
|
9.66 index units
Standard Deviation 10.513
|
9.36 index units
Standard Deviation 10.236
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 82
|
-30.48 index units
Standard Deviation 12.878
|
-30.58 index units
Standard Deviation 14.404
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Core Baseline Actual Values
|
40.20 index units
Standard Deviation 11.252
|
40.06 index units
Standard Deviation 11.605
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 12 OLE Actual Values
|
10.92 index units
Standard Deviation 9.349
|
10.54 index units
Standard Deviation 9.106
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 12
|
-29.35 index units
Standard Deviation 12.093
|
-29.54 index units
Standard Deviation 12.946
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 20 OLE Actual Values
|
10.30 index units
Standard Deviation 9.489
|
9.90 index units
Standard Deviation 8.755
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 20
|
-29.87 index units
Standard Deviation 12.553
|
-30.23 index units
Standard Deviation 12.821
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 28 OLE Actual Values
|
9.77 index units
Standard Deviation 8.583
|
9.85 index units
Standard Deviation 8.696
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 28
|
-30.35 index units
Standard Deviation 12.111
|
-30.36 index units
Standard Deviation 12.849
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 40 OLE Actual Values
|
9.19 index units
Standard Deviation 8.498
|
9.34 index units
Standard Deviation 8.235
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Change from Core Baseline at week 40
|
-30.88 index units
Standard Deviation 11.992
|
-30.80 index units
Standard Deviation 13.025
|
|
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Week 52 OLE Actual Values
|
8.69 index units
Standard Deviation 7.954
|
8.61 index units
Standard Deviation 7.776
|
Adverse Events
Treatment Arm 1: OKZ 64 mg q4w + MTX
Serious events: 129 serious events
Other events: 356 other events
Deaths: 13 deaths
Treatment Arm 2: OKZ 64 mg q2w + MTX
Serious events: 120 serious events
Other events: 386 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 participants at risk
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 participants at risk
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.67%
7/1043 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.66%
7/1061 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Cellulitis
|
0.67%
7/1043 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.38%
4/1061 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Erysipelas
|
0.48%
5/1043 • Number of events 5 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.38%
4/1061 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
COVID-19
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.28%
3/1061 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Pyelonephritis acute
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Pyelonephritis
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Sepsis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.28%
3/1061 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Abscess limb
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Atypical pneumonia
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Bullous erysipelas
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Cat scratch disease
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Device related infection
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Encephalomyelitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Gangrene
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Influenza
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Intervertebral discitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Joint abscess
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Localised infection
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Ludwig angina
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Post procedural infection
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Renal abscess
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Salpingo-oophoritis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Scrotal abscess
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Septic shock
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Viral infection
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Wound infection pseudomonas
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.58%
6/1043 • Number of events 6 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.57%
6/1061 • Number of events 6 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
3/1043 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Arrhythmia
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.38%
4/1043 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.19%
2/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Syncope
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Encephalopathy
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Migraine
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Myelopathy
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Pineal gland cyst
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Seizure
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.38%
4/1061 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Investigations
Alanine aminotransferase increased
|
0.67%
7/1043 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.47%
5/1061 • Number of events 6 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Investigations
Hepatic enzyme increased
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Investigations
Liver function test increased
|
0.10%
1/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Biliary colic
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Hepatobiliary disorders
Liver injury
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Death
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Sudden death
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Lithiasis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Pyrexia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Sudden cardiac death
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.19%
2/1043 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Shock haemorrhagic
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Varicose vein
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Renal and urinary disorders
Calculus urinary
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Renal and urinary disorders
Nephritis
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Renal and urinary disorders
Renal colic
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Splenic cyst
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Eye disorders
Cataract
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Eye disorders
Ocular myasthenia
|
0.00%
0/1043 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.09%
1/1061 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Immune system disorders
Hypersensitivity
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Psychiatric disorders
Completed suicide
|
0.10%
1/1043 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
0.00%
0/1061 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
Other adverse events
| Measure |
Treatment Arm 1: OKZ 64 mg q4w + MTX
n=1043 participants at risk
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
Treatment Arm 2: OKZ 64 mg q2w + MTX
n=1061 participants at risk
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.8%
71/1043 • Number of events 90 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
8.2%
87/1061 • Number of events 108 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
59/1043 • Number of events 70 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
6.3%
67/1061 • Number of events 84 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Infections and infestations
Bronchitis
|
5.7%
59/1043 • Number of events 66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
4.2%
45/1061 • Number of events 51 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
95/1043 • Number of events 156 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
10.8%
115/1061 • Number of events 194 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
52/1043 • Number of events 80 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
5.9%
63/1061 • Number of events 94 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.4%
46/1043 • Number of events 66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
5.7%
60/1061 • Number of events 95 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
42/1043 • Number of events 79 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
5.4%
57/1061 • Number of events 92 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.9%
41/1043 • Number of events 62 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
4.7%
50/1061 • Number of events 90 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
25/1043 • Number of events 25 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
4.0%
42/1061 • Number of events 44 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
|
Vascular disorders
Hypertension
|
3.1%
32/1043 • Number of events 33 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
4.1%
44/1061 • Number of events 49 • Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
|
Additional Information
Sergey Grishin, Head of Scientific Affairs Department
R-Pharm
Phone: 0074959567937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study related information could be made public available only after Sponsors written permission.
- Publication restrictions are in place
Restriction type: OTHER