Trial Outcomes & Findings for PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study (NCT NCT04129931)
NCT ID: NCT04129931
Last Updated: 2026-04-01
Results Overview
Assessed prior to bronchodilator administration. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
950 participants
Primary outcome timeframe
Measured at 16 weeks after the start of treatment.
Results posted on
2026-04-01
Participant Flow
Participant milestones
| Measure |
All Participants
Participants could receive multiple interventions in different sequences under a multi-period crossover design wtih over 200 possible sequences.
Clazakizumab: 12.5 mg subcutaneous injection given once every 4 weeks for 16 weeks. Lab driven dose reductions made based on safety lab data.
Clazakizumab Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks for 16 weeks
Medium ChainTriglycerides (MCT): Mix 2.5 packets daily into liquid or food for 16 weeks
MCT Placebo: MCT-matching placebo packets. Mix 2-5 packets daily into liquid or food for 16 weeks
Imatinib Mesylate: Two 100 mg tablets orally once a day with a meal and 8 oz water for 2 weeks. If well tolerated, participants titrated up to 4-100 mg tablets once daily with a meal and 8 oz water for 14 weeks
Imatinib Placebo: Two 100 mg placebo tablets orally once a day with a meal and 8 oz water for 2 weeks. Then four 100 mg placebo tablets once a day with a meal and 8 oz water for 14 weeks
Broncho-Vaxom: 7 mg taken orally once a day, on an empty stomach, for 16 weeks
Broncho-Vaxom Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks
Cavosonstat: 50 mg capsule orally twice a day for 16 weeks
Cavosonstat Placebo: 50 mg matching placebo capsule orally twice a day for 16 weeks
|
|---|---|
|
Screening and Run-In
STARTED
|
950
|
|
Screening and Run-In
Completed Biomarker Assessment
|
467
|
|
Screening and Run-In
Post Run-In
|
437
|
|
Screening and Run-In
Randomized
|
358
|
|
Screening and Run-In
COMPLETED
|
358
|
|
Screening and Run-In
NOT COMPLETED
|
592
|
|
Period 1 (16 Weeks)
STARTED
|
358
|
|
Period 1 (16 Weeks)
Cavosonstat
|
23
|
|
Period 1 (16 Weeks)
Cavosonstat Matching Placebo
|
28
|
|
Period 1 (16 Weeks)
Broncho-Vaxom
|
28
|
|
Period 1 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
34
|
|
Period 1 (16 Weeks)
Imatinib
|
54
|
|
Period 1 (16 Weeks)
Imatinib Matching Placebo
|
43
|
|
Period 1 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
38
|
|
Period 1 (16 Weeks)
MCT Matching Placebo
|
33
|
|
Period 1 (16 Weeks)
Clazakizumab
|
44
|
|
Period 1 (16 Weeks)
Clazakizumab Matching Placebo
|
33
|
|
Period 1 (16 Weeks)
COMPLETED
|
345
|
|
Period 1 (16 Weeks)
NOT COMPLETED
|
13
|
|
Period 1 Washout (8 or 16 Weeks)
STARTED
|
345
|
|
Period 1 Washout (8 or 16 Weeks)
COMPLETED
|
281
|
|
Period 1 Washout (8 or 16 Weeks)
NOT COMPLETED
|
64
|
|
Period 2 (16 Weeks)
STARTED
|
281
|
|
Period 2 (16 Weeks)
Cavosonstat
|
22
|
|
Period 2 (16 Weeks)
Cavosonstat Matching Placebo
|
21
|
|
Period 2 (16 Weeks)
Broncho-Vaxom
|
25
|
|
Period 2 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
21
|
|
Period 2 (16 Weeks)
Imatinib
|
34
|
|
Period 2 (16 Weeks)
Imatinib Matching Placebo
|
42
|
|
Period 2 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
28
|
|
Period 2 (16 Weeks)
MCT Matching Placebo
|
32
|
|
Period 2 (16 Weeks)
Clazakizumab
|
24
|
|
Period 2 (16 Weeks)
Clazakizumab Matching Placebo
|
32
|
|
Period 2 (16 Weeks)
COMPLETED
|
275
|
|
Period 2 (16 Weeks)
NOT COMPLETED
|
6
|
|
Period 2 Washout (8 or 16 Weeks)
STARTED
|
275
|
|
Period 2 Washout (8 or 16 Weeks)
COMPLETED
|
174
|
|
Period 2 Washout (8 or 16 Weeks)
NOT COMPLETED
|
101
|
|
Period 3 (16 Weeks)
STARTED
|
174
|
|
Period 3 (16 Weeks)
Cavosonstat
|
24
|
|
Period 3 (16 Weeks)
Cavosonstat Matching Placebo
|
6
|
|
Period 3 (16 Weeks)
Broncho-Vaxom
|
35
|
|
Period 3 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
6
|
|
Period 3 (16 Weeks)
Imatinib
|
27
|
|
Period 3 (16 Weeks)
Imatinib Matching Placebo
|
5
|
|
Period 3 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
24
|
|
Period 3 (16 Weeks)
MCT Matching Placebo
|
9
|
|
Period 3 (16 Weeks)
Clazakizumab
|
28
|
|
Period 3 (16 Weeks)
Clazakizumab Matching Placebo
|
10
|
|
Period 3 (16 Weeks)
COMPLETED
|
170
|
|
Period 3 (16 Weeks)
NOT COMPLETED
|
4
|
|
Period 3 Washout (8 or 16 Weeks)
STARTED
|
170
|
|
Period 3 Washout (8 or 16 Weeks)
COMPLETED
|
100
|
|
Period 3 Washout (8 or 16 Weeks)
NOT COMPLETED
|
70
|
|
Period 4 (16 Weeks)
STARTED
|
100
|
|
Period 4 (16 Weeks)
Cavosonstat
|
25
|
|
Period 4 (16 Weeks)
Cavosonstat Matching Placebo
|
2
|
|
Period 4 (16 Weeks)
Broncho-Vaxom
|
20
|
|
Period 4 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
4
|
|
Period 4 (16 Weeks)
Imatinib
|
14
|
|
Period 4 (16 Weeks)
Imatinib Matching Placebo
|
2
|
|
Period 4 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
15
|
|
Period 4 (16 Weeks)
MCT Matching Placebo
|
2
|
|
Period 4 (16 Weeks)
Clazakizumab
|
14
|
|
Period 4 (16 Weeks)
Clazakizumab Matching Placebo
|
2
|
|
Period 4 (16 Weeks)
COMPLETED
|
98
|
|
Period 4 (16 Weeks)
NOT COMPLETED
|
2
|
|
Period 4 Washout (8 or 16 Weeks)
STARTED
|
98
|
|
Period 4 Washout (8 or 16 Weeks)
COMPLETED
|
49
|
|
Period 4 Washout (8 or 16 Weeks)
NOT COMPLETED
|
49
|
|
Period 5 (16 Weeks)
STARTED
|
49
|
|
Period 5 (16 Weeks)
Cavosonstat
|
4
|
|
Period 5 (16 Weeks)
Cavosonstat Matching Placebo
|
0
|
|
Period 5 (16 Weeks)
Broncho-Vaxom
|
16
|
|
Period 5 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
2
|
|
Period 5 (16 Weeks)
Imatinib
|
7
|
|
Period 5 (16 Weeks)
Imatinib Matching Placebo
|
1
|
|
Period 5 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
11
|
|
Period 5 (16 Weeks)
MCT Matching Placebo
|
0
|
|
Period 5 (16 Weeks)
Clazakizumab
|
8
|
|
Period 5 (16 Weeks)
Clazakizumab Matching Placebo
|
0
|
|
Period 5 (16 Weeks)
COMPLETED
|
49
|
|
Period 5 (16 Weeks)
NOT COMPLETED
|
0
|
|
Period 5 Washout (8 or 16 Weeks)
STARTED
|
49
|
|
Period 5 Washout (8 or 16 Weeks)
COMPLETED
|
13
|
|
Period 5 Washout (8 or 16 Weeks)
NOT COMPLETED
|
36
|
|
Period 6 (16 Weeks)
STARTED
|
13
|
|
Period 6 (16 Weeks)
Cavosonstat
|
1
|
|
Period 6 (16 Weeks)
Cavosonstat Matching Placebo
|
1
|
|
Period 6 (16 Weeks)
Broncho-Vaxom
|
5
|
|
Period 6 (16 Weeks)
Broncho-Vaxom Matching Placebo
|
0
|
|
Period 6 (16 Weeks)
Imatinib
|
0
|
|
Period 6 (16 Weeks)
Imatinib Matching Placebo
|
0
|
|
Period 6 (16 Weeks)
Medium Chain Triglycerides (MCT)
|
4
|
|
Period 6 (16 Weeks)
MCT Matching Placebo
|
0
|
|
Period 6 (16 Weeks)
Clazakizumab
|
2
|
|
Period 6 (16 Weeks)
Clazakizumab Matching Placebo
|
0
|
|
Period 6 (16 Weeks)
COMPLETED
|
13
|
|
Period 6 (16 Weeks)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
Baseline characteristics by cohort
| Measure |
All Participants
n=358 Participants
This is a multi-period crossover where each participant can participant in up to 6 treatment periods. At the start of each treatment period participants are randomized to one of the 5 interventions, Medium Chain Triglycerides (MCT), cavosonstat, imatinib, clazakizumab and Broncho-Vaxom or their matching placebos.
|
|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
358 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 16 weeks after the start of treatment.Assessed prior to bronchodilator administration. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo.
Outcome measures
| Measure |
Broncho-Vaxom
n=125 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=72 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=135 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=85 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=132 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=135 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=119 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=128 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=117 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=127 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Percent Predicted
|
70 percent predicted
Interval 66.2 to 73.8
|
65.6 percent predicted
Interval 61.2 to 70.0
|
69.5 percent predicted
Interval 66.0 to 72.9
|
66.0 percent predicted
Interval 61.4 to 70.6
|
70.1 percent predicted
Interval 66.6 to 73.5
|
69.2 percent predicted
Interval 65.8 to 72.6
|
73.8 percent predicted
Interval 69.5 to 78.2
|
73.80 percent predicted
Interval 69.1 to 76.8
|
70.3 percent predicted
Interval 66.8 to 73.8
|
69.1 percent predicted
Interval 65.8 to 72.5
|
PRIMARY outcome
Timeframe: Measured at 16 weeks after the start of treatment.Asthma symptom control is assessed via ACQ-6, the average score of these six items (range 0-6). The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled'. Negative change from baseline values indicate improved asthma control. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo.
Outcome measures
| Measure |
Broncho-Vaxom
n=124 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=72 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=136 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=85 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=132 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=136 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=119 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=129 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=117 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=127 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
The Juniper Asthma Control Questionnaire (ACQ-6)
|
1.5 score on a scale
Interval 1.3 to 1.7
|
1.8 score on a scale
Interval 1.5 to 2.0
|
1.5 score on a scale
Interval 1.3 to 1.7
|
1.6 score on a scale
Interval 1.4 to 1.8
|
1.7 score on a scale
Interval 1.5 to 1.9
|
1.6 score on a scale
Interval 1.4 to 1.8
|
1.4 score on a scale
Interval 1.3 to 1.6
|
1.4 score on a scale
Interval 1.2 to 1.6
|
1.6 score on a scale
Interval 1.4 to 1.7
|
1.4 score on a scale
Interval 1.3 to 1.6
|
SECONDARY outcome
Timeframe: Assessed over 16 weeks of treatmentComposite outcome with exacerbations (CompEx) is an outcome specific to asthma and chronic obstructive pulmonary disease (COPD) that combines clinically-relevant deteriorations with exacerbations. Deterioration events defined based on daily recordings of peak expiratory flow (PEF) morning/evening (L/min), reliever use morning/evening (doses), symptoms morning/evening (score 0-3) from twice-daily recordings. Participants are asked to describe their morning and evening symptoms using the following scale: 0-No symptoms to report, 3-I could not sleep because of my asthma/I could not perform my normal activities because of my asthma.
Outcome measures
| Measure |
Broncho-Vaxom
n=107 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=62 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=129 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=82 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=119 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=124 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=106 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=114 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=103 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=114 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
CompEx Events Per Year
|
1.8 CompEx events per year
Interval 1.3 to 2.3
|
1.0 CompEx events per year
Interval 0.6 to 1.7
|
1.8 CompEx events per year
Interval 1.2 to 2.4
|
2.7 CompEx events per year
Interval 1.7 to 3.6
|
1.75 CompEx events per year
Interval 1.12 to 2.38
|
1.78 CompEx events per year
Interval 1.2 to 2.36
|
1.7 CompEx events per year
Interval 0.8 to 1.7
|
1.6 CompEx events per year
Interval 1.0 to 2.2
|
1.3 CompEx events per year
Interval 0.8 to 1.8
|
1.4 CompEx events per year
Interval 0.8 to 1.9
|
SECONDARY outcome
Timeframe: Measured at 16 weeks after the start of treatment.Assessed prior to bronchodilator administration
Outcome measures
| Measure |
Broncho-Vaxom
n=124 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=72 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=135 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=85 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=132 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=135 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=119 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=128 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=117 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=127 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Vital Capacity (FVC) Pre-bronchodilation
|
90.8 % predicted
Interval 87.0 to 94.8
|
85.3 % predicted
Interval 81.5 to 89.1
|
90.4 % predicted
Interval 87.0 to 93.9
|
85.3 % predicted
Interval 81.4 to 89.1
|
89.7 % predicted
Interval 86.4 to 93.0
|
89.2 % predicted
Interval 86.3 to 92.0
|
93.2 % predicted
Interval 88.5 to 96.1
|
92.1 % predicted
Interval 88.5 to 95.1
|
87.9 % predicted
Interval 84.8 to 91.0
|
86.8 % predicted
Interval 83.9 to 89.7
|
SECONDARY outcome
Timeframe: Measured at 16 weeks after the start of treatment.Assessed after 4 puffs of bronchodilator administration
Outcome measures
| Measure |
Broncho-Vaxom
n=107 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=65 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=123 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=37 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=112 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=121 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=107 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=112 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=111 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=115 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
FEV1 % Predicted Post-bronchodilation
|
77.3 percent predicted
Interval 73.2 to 81.4
|
72.3 percent predicted
Interval 67.7 to 76.9
|
78.9 percent predicted
Interval 75.2 to 82.5
|
73.4 percent predicted
Interval 66.0 to 80.7
|
78.8 percent predicted
Interval 74.9 to 82.7
|
76.0 percent predicted
Interval 72.6 to 79.5
|
81.6 percent predicted
Interval 77.4 to 85.8
|
82.3 percent predicted
Interval 78.2 to 86.4
|
76.5 percent predicted
Interval 73.0 to 80.0
|
76.9 percent predicted
Interval 73.2 to 80.5
|
SECONDARY outcome
Timeframe: Assessed over 16 weeks of treatmentAnnualized rate of severe exacerbations during the 16-week treatment periods, modified intent-to-treat (mITT) population. An asthma exacerbation in PrecISE is defined as a worsening of asthma requiring the use of a systemic corticosteroid (at least 3 days of treatment) to prevent a serious outcome.
Outcome measures
| Measure |
Broncho-Vaxom
n=107 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=62 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=129 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=82 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=119 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=124 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=119 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=129 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=103 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=114 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Exacerbations
|
0.54 exacerbations per year
Interval 0.28 to 0.79
|
0.40 exacerbations per year
Interval 0.08 to 0.73
|
0.39 exacerbations per year
Interval 0.18 to 0.6
|
0.69 exacerbations per year
Interval 0.33 to 1.05
|
0.73 exacerbations per year
Interval 0.29 to 1.18
|
0.61 exacerbations per year
Interval 0.29 to 0.94
|
0.36 exacerbations per year
Interval 0.11 to 0.61
|
0.37 exacerbations per year
Interval 0.09 to 0.66
|
0.55 exacerbations per year
Interval 0.25 to 0.85
|
0.64 exacerbations per year
Interval 0.27 to 1.02
|
SECONDARY outcome
Timeframe: Assessed over 16 weeks of treatmentAn asthma free day is a day where 1) there is no use of albuterol rescue (excluding the use of albuterol as pre-exercise treatment), 2) no daytime or nighttime asthma symptoms, 3) no peak expiratory flow of less than 80% of the predetermined reference value.
Outcome measures
| Measure |
Broncho-Vaxom
n=105 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=62 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=149 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=94 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=119 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=135 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=105 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=135 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=101 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=131 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With At Least One Asthma-Free Day
|
57 Participants
|
29 Participants
|
79 Participants
|
45 Participants
|
51 Participants
|
60 Participants
|
50 Participants
|
65 Participants
|
50 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Assessed over 16 weeks of treatmentA symptom free day is a day with no asthma symptoms (symptom score = 0) for both morning and evening daily diary entries.
Outcome measures
| Measure |
Broncho-Vaxom
n=105 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=62 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=149 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=94 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=119 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=135 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=106 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=135 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=102 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=131 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With At Least One Symptom-free Day
|
64 Participants
|
32 Participants
|
88 Participants
|
52 Participants
|
57 Participants
|
68 Participants
|
55 Participants
|
72 Participants
|
57 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Assessed over 16 weeks of treatmentThe combined total number of: asthma-specific Emergency Department visits, asthma-specific hospital admissions, and asthma-specific ICU admissions. The investigators report the number of participants with at least one asthma-specific Emergency Department visit, asthma-specific hospital admission, or asthma-specific ICU admission
Outcome measures
| Measure |
Broncho-Vaxom
n=124 Participants
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study.
|
Cavosonstat
n=72 Participants
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
|
Broncho-Vaxom Arm Placebo
n=136 Participants
For this arm, study treatment may include Broncho-Vaxom matched placebo or non-Broncho-Vaxom matched placebo. Minimally, all Broncho-Vaxom matched placebo is included. If a Broncho-Vaxom matched placebo was unavailable for a participant who was randomized to active Broncho-Vaxom, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Cavosonstat Arm Placebo
n=85 Participants
For this arm, study treatment may include cavosonstat matched placebo or non cavosonstat matched placebo. Minimally, all cavosonstat matched placebo is included. If a cavosonstat matched placebo was unavailable for a participant who was randomized to active cavosonstat, any placebo (up to a maximum of two placebos) administered to the participant was included. Only the biomarker positive subgroup participants with ADH5 genotypes rs7669660 TT and rs11547772 AA are included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Imatinib
n=132 Participants
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
|
Imatinib Arm Placebo
n=136 Participants
For this arm, study treatment may include imatinib matched placebo or non-imatinib matched placebo. Minimally, all imatinib matched placebo is included. If an imatinib matched placebo was unavailable for a participant who was randomized to active imatinib, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=119 Participants
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily during the 16-week treatment period. Participants will mix 2-5 packets of MCT supplement powder into liquids or semi-solid food daily.
|
MCT Arm Placebo
n=129 Participants
For this arm, study treatment may include MCT matched placebo or non- MCT matched placebo. Minimally, all MCT matched placebo is included. If an MCT matched placebo was unavailable for a participant who was randomized to active MCT, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Clazakizumab
n=117 Participants
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab Arm Placebo
n=127 Participants
For this arm, study treatment may include clazakizumab matched placebo or non-clazakizumab matched placebo. Minimally, all clazakizumab matched placebo is included. If a clazakizumab matched placebo was unavailable for a participant who was randomized to active clazakizumab, any placebo (up to a maximum of two placebos) administered to the participant was included.
The following placebos are available:
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets into liquid or food daily for 16 weeks Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Healthcare Utilization
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Run-in Period
Serious events: 19 serious events
Other events: 74 other events
Deaths: 0 deaths
Cavosonstat
Serious events: 10 serious events
Other events: 65 other events
Deaths: 2 deaths
Cavosonstat-Matching Placebo
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Broncho-Vaxom
Serious events: 4 serious events
Other events: 82 other events
Deaths: 0 deaths
Broncho-Vaxom-Matching Placebo
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Imatinib
Serious events: 12 serious events
Other events: 105 other events
Deaths: 0 deaths
Imatinib-Matching Placebo
Serious events: 9 serious events
Other events: 65 other events
Deaths: 0 deaths
Medium Chain Triglycerides (MCT)
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
MCT-Matching Placebo
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
Clazakizumab
Serious events: 9 serious events
Other events: 92 other events
Deaths: 0 deaths
Clazakizumab-Matching Placebo
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-in Period
n=950 participants at risk
Participants using their asthma control medication were assessed for lung function and symptoms
|
Cavosonstat
n=99 participants at risk
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study
|
Cavosonstat-Matching Placebo
n=57 participants at risk
Participants who receive cavosonstat matched placebo
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks
|
Broncho-Vaxom
n=126 participants at risk
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study
|
Broncho-Vaxom-Matching Placebo
n=66 participants at risk
Participants who receive Broncho-Vaxom matched placebo
Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks
|
Imatinib
n=133 participants at risk
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks
|
Imatinib-Matching Placebo
n=92 participants at risk
Participants who receive imatinib matched placebo
Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=120 participants at risk
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (10 g each) at each treatment visit at any point in the study. Participants will mix 1-2 packets of MCT supplement powder into liquids or semi-solid food and ingest 3 times a day during the 16-week treatment period
|
MCT-Matching Placebo
n=76 participants at risk
Participants who receive MCT matched placebo
MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets daily into liquid or food for 16 weeks
|
Clazakizumab
n=118 participants at risk
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab-Matching Placebo
n=77 participants at risk
Participants who receive clazakizumab matched placebo
Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
3/950 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.3%
3/133 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.2%
2/92 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Migraine
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Syncope
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
COVID-19
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
2/133 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Surgical and medical procedures
Acute kidney injury
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.21%
2/950 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Vascular disorders
Transient ischaemic attack
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Sepsis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Reproductive system and breast disorders
Breast cancer
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
2/133 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Reproductive system and breast disorders
Invasive ductal breast carcinoma
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
General disorders
Flank pain
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Serotonin syndrome
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Surgical and medical procedures
Pancreaticoduodenectomy
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.3%
3/133 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Investigations
Troponin I increased
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Meningitis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
intestinal preferation
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
colitis ulcerative
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Psychiatric disorders
suicidal ideation
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Psychiatric disorders
depression
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
oedema peripheral
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
craniocerebral injury
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
urosepsis
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
diverticulatis
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
somnolence
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Cardiac disorders
hypotension
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/118 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
Other adverse events
| Measure |
Run-in Period
n=950 participants at risk
Participants using their asthma control medication were assessed for lung function and symptoms
|
Cavosonstat
n=99 participants at risk
Participants randomized to this arm will take one 50 mg cavosonstat tablet orally twice a day for the 16-week treatment period duration at any point in the study
|
Cavosonstat-Matching Placebo
n=57 participants at risk
Participants who receive cavosonstat matched placebo
Cavosonstat Matching Placebo: 50 mg matching placebo tablet orally twice a day for 16 weeks
|
Broncho-Vaxom
n=126 participants at risk
Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study
|
Broncho-Vaxom-Matching Placebo
n=66 participants at risk
Participants who receive Broncho-Vaxom matched placebo
Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks
|
Imatinib
n=133 participants at risk
At any point in the study, participants randomized to this arm will take two encapsulated 100 mg imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four encapsulated 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks
|
Imatinib-Matching Placebo
n=92 participants at risk
Participants who receive imatinib matched placebo
Imatinib Matching Placebo: encapsulated placebo orally once a day with a meal and an 8 oz glass of water for 16 weeks
|
Medium Chain Triglycerides (MCT)
n=120 participants at risk
Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (10 g each) at each treatment visit at any point in the study. Participants will mix 1-2 packets of MCT supplement powder into liquids or semi-solid food and ingest 3 times a day during the 16-week treatment period
|
MCT-Matching Placebo
n=76 participants at risk
Participants who receive MCT matched placebo
MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets daily into liquid or food for 16 weeks
|
Clazakizumab
n=118 participants at risk
Participants randomized to this arm will receive a 12.5 mg dose of clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, 4 injections total, during the 16-week treatment period
|
Clazakizumab-Matching Placebo
n=77 participants at risk
Participants who receive clazakizumab matched placebo
Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks, total of 4 injections
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.3%
3/133 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
8.3%
10/120 • Number of events 10 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
4/76 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
2/950 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.8%
6/126 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.5%
3/66 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
7/133 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.2%
2/92 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.0%
6/120 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.5%
3/118 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.74%
7/950 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.0%
4/99 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.0%
4/57 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
4/133 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.4%
5/92 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
4/120 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/76 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.4%
4/118 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
3/950 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.6%
2/126 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.2%
5/118 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Bronchitis
|
0.32%
3/950 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
3/99 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.6%
2/126 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
4/133 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.5%
5/77 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
COVID-19
|
0.21%
2/950 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.1%
10/99 • Number of events 10 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
15.8%
9/57 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
11.9%
15/126 • Number of events 15 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
7/133 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.6%
7/92 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.5%
9/120 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.2%
7/76 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
11.0%
13/118 • Number of events 13 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
14.3%
11/77 • Number of events 11 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.5%
3/66 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.2%
2/92 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
4/120 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.8%
5/133 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.3%
4/92 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.9%
7/118 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.84%
8/950 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.5%
12/126 • Number of events 12 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.8%
5/133 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.3%
4/92 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
4/120 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/76 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.8%
8/118 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
4/950 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.6%
5/66 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.8%
13/133 • Number of events 13 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
3/92 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.0%
12/120 • Number of events 12 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
4/76 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.3%
11/118 • Number of events 11 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
3/99 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.75%
1/133 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
3/92 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.5%
3/118 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
General disorders
Fatigue
|
0.32%
3/950 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
4/133 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.83%
1/120 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
4/76 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.4%
4/118 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.42%
4/950 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
3/99 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/76 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Nervous system disorders
Headache
|
0.63%
6/950 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.1%
5/99 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.2%
4/126 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
7/133 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.4%
5/92 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.0%
6/120 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.6%
5/76 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.1%
6/118 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
General disorders
Injection site reaction
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/57 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/92 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.2%
12/118 • Number of events 12 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/77 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
3/99 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
21.8%
29/133 • Number of events 29 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.4%
5/92 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.42%
4/950 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.6%
2/126 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.5%
1/66 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
8.3%
11/133 • Number of events 11 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
3/92 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.4%
4/118 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.1%
7/99 • Number of events 7 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.5%
6/57 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.1%
9/126 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.1%
4/66 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.8%
9/133 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.4%
5/92 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
4/120 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.9%
6/76 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.3%
11/118 • Number of events 11 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
11.7%
9/77 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Nausea
|
0.21%
2/950 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.0%
5/126 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
19.5%
26/133 • Number of events 26 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.4%
5/92 • Number of events 5 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.7%
8/120 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
4/76 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
General disorders
Oedema
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.0%
8/133 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.1%
1/92 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/77 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Oral candidiasis
|
0.84%
8/950 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
3/99 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.0%
4/57 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.79%
1/126 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.3%
3/133 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
3/92 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
4/120 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/76 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.7%
2/118 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/99 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
3/57 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/133 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.2%
2/92 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/76 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.5%
3/118 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
3/950 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.0%
2/99 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.4%
3/126 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/66 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.8%
9/133 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.3%
3/92 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/120 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
12.7%
15/118 • Number of events 15 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Infections and infestations
Sinusitis
|
1.4%
13/950 • Number of events 13 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.0%
4/99 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.5%
2/57 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.8%
6/126 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
9.1%
6/66 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.0%
8/133 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
4.3%
4/92 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
6.7%
8/120 • Number of events 8 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
7.9%
6/76 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
14.4%
17/118 • Number of events 17 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.9%
3/77 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
1/950 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.0%
1/99 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.8%
1/57 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.00%
0/126 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
3.0%
2/66 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.3%
3/133 • Number of events 3 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.2%
2/92 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.0%
6/120 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
2.6%
2/76 • Number of events 2 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
0.85%
1/118 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
1.3%
1/77 • Number of events 1 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/950 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.1%
10/99 • Number of events 10 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.5%
6/57 • Number of events 6 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.3%
13/126 • Number of events 13 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
13.6%
9/66 • Number of events 9 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
11.3%
15/133 • Number of events 15 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
10.9%
10/92 • Number of events 10 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
11.7%
14/120 • Number of events 14 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
5.3%
4/76 • Number of events 4 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
16.9%
20/118 • Number of events 20 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
15.6%
12/77 • Number of events 12 • The observation time began with run-in and continued through the total number of treatment and washout periods. The maximum observation time was 124 weeks. Adverse events are reported for each treatment period combined with the washout. The length of treatment period combined with washout is 16 weeks of treatment plus 8 weeks washout (except 16 weeks washout following clazakizumab).
|
Additional Information
Anastasia Ivanova, PhD
University of North Carolina at Chapel Hill
Phone: 919-843-8086
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place