Trial Outcomes & Findings for Effects of Abatacept in Patients With Early Rheumatoid Arthritis (NCT NCT02504268)
NCT ID: NCT02504268
Last Updated: 2021-06-28
Results Overview
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
994 participants
Primary outcome timeframe
Week 24
Results posted on
2021-06-28
Participant Flow
994 treated in the induction period (IP). 184 from IP randomized and treated in De-Escalation (DeE), 685 treated in the Open Label (OL) and 120 treated in the Open Label Extension (OLE) period. Participants in IP could move to the OL period after IP completion or through early IP escape. Participants from DeE could transfer to OL through early escape or to OLE after completing DeE.
Participant milestones
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
451
|
301
|
242
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Induction to Open Label
|
289
|
196
|
147
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Early Escaped to Open Label
|
10
|
21
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Induction to De-Escalation
|
94
|
37
|
53
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized in De-Escalation Period
|
0
|
0
|
0
|
50
|
50
|
47
|
37
|
0
|
0
|
|
Overall Study
De-Escalation to Open Label Extension
|
0
|
0
|
0
|
36
|
30
|
32
|
22
|
0
|
0
|
|
Overall Study
Early Escaped De-Escalation to Open Label Period
|
0
|
0
|
0
|
2
|
5
|
4
|
3
|
0
|
0
|
|
Overall Study
Open Label and Open Label Extension Period
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
685
|
120
|
|
Overall Study
COMPLETED
|
388
|
233
|
201
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
63
|
68
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
8
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
11
|
10
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject Request to Discontinue
|
11
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
No Longer Meets Study Criteria
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
11
|
35
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Poor/Non-Compliance
|
3
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Not Disclosed
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Ethnicity data was collected for US Subjects only.
Baseline characteristics by cohort
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=451 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=301 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
n=242 Participants
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Total
n=994 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 12.74 • n=451 Participants
|
48.8 years
STANDARD_DEVIATION 13.99 • n=301 Participants
|
50.0 years
STANDARD_DEVIATION 12.91 • n=242 Participants
|
49.1 years
STANDARD_DEVIATION 13.17 • n=994 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=451 Participants
|
243 Participants
n=301 Participants
|
189 Participants
n=242 Participants
|
781 Participants
n=994 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=451 Participants
|
58 Participants
n=301 Participants
|
53 Participants
n=242 Participants
|
213 Participants
n=994 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
315 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
209 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
174 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
698 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
BLACK/AFRICAN AMERICAN
|
20 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
16 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
7 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
43 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN/ALASKA NATIVE
|
0 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
3 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
1 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
4 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
ASIAN
|
77 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
52 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
11 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
140 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
RACE - OTHER/ NOT REPORTED
|
39 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
21 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
49 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
109 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
8 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
5 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
9 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
22 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
43 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
37 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
32 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
112 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
Race/Ethnicity, Customized
ETHNICITY - NOT REPORTED
|
400 Participants
n=451 Participants • Ethnicity data was collected for US Subjects only.
|
259 Participants
n=301 Participants • Ethnicity data was collected for US Subjects only.
|
201 Participants
n=242 Participants • Ethnicity data was collected for US Subjects only.
|
860 Participants
n=994 Participants • Ethnicity data was collected for US Subjects only.
|
|
MODIFIED SHARP/VAN DER HEIJDE TOTAL SCORE (mTSS)
|
9.82 Scores on a scale
STANDARD_DEVIATION 16.342 • n=442 Participants • Cohort 1 Analysis Population
|
12.99 Scores on a scale
STANDARD_DEVIATION 19.769 • n=292 Participants • Cohort 1 Analysis Population
|
—
|
11.08 Scores on a scale
STANDARD_DEVIATION 17.839 • n=734 Participants • Cohort 1 Analysis Population
|
|
Tender Joints - 28
|
13.2 Joint Count
STANDARD_DEVIATION 6.76 • n=448 Participants • Cohort 1 Analysis Population
|
13.7 Joint Count
STANDARD_DEVIATION 6.77 • n=298 Participants • Cohort 1 Analysis Population
|
—
|
13.4 Joint Count
STANDARD_DEVIATION 6.76 • n=746 Participants • Cohort 1 Analysis Population
|
|
Swollen Joints - 28
|
10.0 Joint Count
STANDARD_DEVIATION 5.71 • n=448 Participants • Cohort 1 Analysis Population
|
10.7 Joint Count
STANDARD_DEVIATION 5.85 • n=298 Participants • Cohort 1 Analysis Population
|
—
|
10.3 Joint Count
STANDARD_DEVIATION 5.77 • n=746 Participants • Cohort 1 Analysis Population
|
|
Subject global assessment of disease activity
|
65.7 mm
STANDARD_DEVIATION 22.7 • n=450 Participants • Cohort 1 Analysis Population
|
62.7 mm
STANDARD_DEVIATION 24.05 • n=301 Participants • Cohort 1 Analysis Population
|
—
|
64.5 mm
STANDARD_DEVIATION 23.28 • n=751 Participants • Cohort 1 Analysis Population
|
|
Physician global assessment of disease activity
|
65.1 mm
STANDARD_DEVIATION 18.48 • n=446 Participants • Cohort 1 Analysis Population
|
66.1 mm
STANDARD_DEVIATION 19.75 • n=296 Participants • Cohort 1 Analysis Population
|
—
|
65.5 mm
STANDARD_DEVIATION 18.99 • n=742 Participants • Cohort 1 Analysis Population
|
|
C-Reactive Protein (CRP)
|
1.998 mg/dL
STANDARD_DEVIATION 2.7062 • n=450 Participants • Cohort 1 Analysis Population
|
1.904 mg/dL
STANDARD_DEVIATION 2.1956 • n=301 Participants • Cohort 1 Analysis Population
|
—
|
1.960 mg/dL
STANDARD_DEVIATION 2.5129 • n=751 Participants • Cohort 1 Analysis Population
|
|
DAS28-CRP
|
5.56 Scores on a scale
STANDARD_DEVIATION 1.062 • n=446 Participants • Cohort 1 Analysis Population
|
5.61 Scores on a scale
STANDARD_DEVIATION 1.032 • n=298 Participants • Cohort 1 Analysis Population
|
—
|
5.58 Scores on a scale
STANDARD_DEVIATION 1.049 • n=744 Participants • Cohort 1 Analysis Population
|
|
SDAI
|
38.24 Scores on a scale
STANDARD_DEVIATION 14.084 • n=443 Participants • Cohort 1 Analysis Population
|
39.36 Scores on a scale
STANDARD_DEVIATION 13.770 • n=294 Participants • Cohort 1 Analysis Population
|
—
|
38.69 Scores on a scale
STANDARD_DEVIATION 13.961 • n=737 Participants • Cohort 1 Analysis Population
|
PRIMARY outcome
Timeframe: Week 24Population: Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
Outcome measures
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=225 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=150 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
|
21.3 Percentage of participants
Interval 16.0 to 26.7
|
16.0 Percentage of participants
Interval 10.1 to 21.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.
DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP \<= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
Outcome measures
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=225 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=150 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
|
38.7 Percentage of Participants
Interval 32.3 to 45.0
|
25.3 Percentage of Participants
Interval 18.4 to 32.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
Outcome measures
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=225 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=150 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in SDAI Remission at Week 52
|
29.8 Percentage of participants
Interval 23.8 to 35.8
|
15.3 Percentage of participants
Interval 9.6 to 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Linear extrapolation imputation.
The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
Outcome measures
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=401 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=249 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
|
0.53 Total Sharp Score
Standard Deviation 2.279
|
2.52 Total Sharp Score
Standard Deviation 6.205
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Non-Responder imputation.
Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Outcome measures
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=451 Participants
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=301 Participants
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in Boolean Remission at Week 52
|
21.5 Percentage of participants
Interval 17.7 to 25.3
|
11.6 Percentage of participants
Interval 8.0 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
Serious events: 32 serious events
Other events: 237 other events
Deaths: 1 deaths
Placebo + Methotrexate (Cohort 1, IP)
Serious events: 9 serious events
Other events: 152 other events
Deaths: 1 deaths
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
Serious events: 23 serious events
Other events: 123 other events
Deaths: 0 deaths
Abatacept + Methotrexate (De-Escalation Period)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 1 deaths
Abatacept Monotherapy (De-Escalation Period)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Methotrexate Monotherapy (De-Escalation Period)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Abatacept + Methotrexate (Open Label Period)
Serious events: 40 serious events
Other events: 230 other events
Deaths: 1 deaths
Abatacept + Methotrexate (Open Label Extension Period)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=451 participants at risk
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=301 participants at risk
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
n=242 participants at risk
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
n=50 participants at risk
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
n=50 participants at risk
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
n=47 participants at risk
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
n=37 participants at risk
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
n=685 participants at risk
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
n=120 participants at risk
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Investigations
Weight decreased
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.44%
2/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Seizure
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Hydrometra
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Reproductive system and breast disorders
Vaginal polyp
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Vascular disorders
Hypotension
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Angina unstable
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Cardiac arrest
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.29%
2/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Endocrine disorders
Goitre
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Eye disorders
Cataract
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Eye disorders
Macular hole
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Malocclusion
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
General disorders
Pyrexia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
2/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Appendicitis
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Pneumonia
|
0.44%
2/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.66%
2/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.29%
2/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
2/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.44%
2/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.33%
1/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
Other adverse events
| Measure |
Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)
n=451 participants at risk
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Placebo + Methotrexate (Cohort 1, IP)
n=301 participants at risk
Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
|
Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)
n=242 participants at risk
Active abatacept SC (125 mg) weekly + methotrexate weekly
|
Abatacept + Methotrexate (De-Escalation Period)
n=50 participants at risk
Active Abatacept SC (125 mg) weekly + MTX weekly
|
Abatacept (End of Week) + Methotrexate (De-Escalation Period)
n=50 participants at risk
Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
|
Abatacept Monotherapy (De-Escalation Period)
n=47 participants at risk
Active Abatacept SC (125 mg) weekly + placebo MTX weekly
|
Methotrexate Monotherapy (De-Escalation Period)
n=37 participants at risk
Placebo Abatacept SC weekly + methotrexate weekly
|
Abatacept + Methotrexate (Open Label Period)
n=685 participants at risk
weekly abatacept SC 125 mg + methotrexate
|
Abatacept + Methotrexate (Open Label Extension Period)
n=120 participants at risk
abatacept SC (125 mg) qw for 24 weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
12/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.0%
18/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.7%
4/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
1/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.5%
10/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
12/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.7%
5/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.8%
14/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.2%
8/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
17/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
12/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
13/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
1/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.9%
13/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
42/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
8.0%
24/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
9.1%
22/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
2/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
1/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.4%
23/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
27/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
8/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.3%
2/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.1%
21/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.7%
2/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
General disorders
Drug intolerance
|
1.6%
7/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.3%
4/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.58%
4/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Bronchitis
|
4.2%
19/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
12/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.6%
16/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.0%
3/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
12.0%
6/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.5%
24/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
13/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.0%
9/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.1%
10/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.0%
3/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.9%
13/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Herpes zoster
|
0.67%
3/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.66%
2/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.41%
1/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.0%
7/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
63/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
14.3%
43/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
14.9%
36/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
2/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
12.0%
6/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
8.5%
4/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
13.5%
5/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
8.6%
59/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.0%
6/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Pharyngitis
|
4.9%
22/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.6%
17/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.8%
14/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.6%
18/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
24/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.3%
16/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
7.4%
18/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
2/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
8.1%
3/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.1%
28/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.5%
3/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
17/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.0%
9/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
13/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
2/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.8%
26/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
24/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.0%
15/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.1%
10/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
4.0%
2/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.9%
20/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
14/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.3%
10/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.7%
9/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.0%
3/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.6%
11/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Investigations
Influenza A virus test positive
|
0.22%
1/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
2/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.15%
1/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Nervous system disorders
Headache
|
6.9%
31/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
7.0%
21/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
3.3%
8/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
1/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
1/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.9%
20/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
15/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.3%
16/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
5.4%
13/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.0%
1/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
1/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
1.6%
11/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.83%
1/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
|
Vascular disorders
Hypertension
|
2.4%
11/451 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.7%
8/301 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
2.1%
5/242 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
6.0%
3/50 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/47 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/37 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.58%
4/685 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
0.00%
0/120 • approximately 54 months
Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER