Trial Outcomes & Findings for Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease (NCT NCT03395184)
NCT ID: NCT03395184
Last Updated: 2024-10-30
Results Overview
SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
Week 12
Results posted on
2024-10-30
Participant Flow
The study consisted of a 12-weeks induction period and a 52-weeks open label extension (OLE) period. The participants who completed induction period, entered the 52-week OLE period.
A total of 645 participants were screened across 26 countries of which 401 were screen failures and 244 participants were randomized in the study.
Participant milestones
| Measure |
Induction Period: Placebo QD
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) once daily (QD) orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
Participants received PF-06651600 (ritlecitinib) 200 milligrams (mg) QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Placebo QD -> Ritlecitinib 50 mg QD
Participants who received placebo matched to ritlecitinib during the induction period were administered ritlecitinib 50 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD
Participants who received ritlecitinib 200 mg /50 mg QD in the induction period were administered ritlecitinib 50 mg QD for 52 weeks in OLE period.
|
OLE Period: Placebo QD -> Brepocitinib 30 mg QD
Participants who received placebo matched to brepocitinib in the induction period were administered brepocitinib 30 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|---|---|---|
|
Induction Period (Up to 12 Weeks)
STARTED
|
79
|
93
|
72
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
COMPLETED
|
68
|
84
|
65
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
NOT COMPLETED
|
11
|
9
|
7
|
0
|
0
|
0
|
0
|
|
OLE Period (Up to 52 Weeks)
STARTED
|
0
|
0
|
0
|
36
|
84
|
32
|
64
|
|
OLE Period (Up to 52 Weeks)
COMPLETED
|
0
|
0
|
0
|
20
|
45
|
21
|
34
|
|
OLE Period (Up to 52 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
16
|
39
|
11
|
30
|
Reasons for withdrawal
| Measure |
Induction Period: Placebo QD
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) once daily (QD) orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
Participants received PF-06651600 (ritlecitinib) 200 milligrams (mg) QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Placebo QD -> Ritlecitinib 50 mg QD
Participants who received placebo matched to ritlecitinib during the induction period were administered ritlecitinib 50 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD
Participants who received ritlecitinib 200 mg /50 mg QD in the induction period were administered ritlecitinib 50 mg QD for 52 weeks in OLE period.
|
OLE Period: Placebo QD -> Brepocitinib 30 mg QD
Participants who received placebo matched to brepocitinib in the induction period were administered brepocitinib 30 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|---|---|---|
|
Induction Period (Up to 12 Weeks)
Adverse Event
|
6
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
No longer meets eligibility criteria
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
Lack of Efficacy
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Induction Period (Up to 12 Weeks)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (Up to 52 Weeks)
Other
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
|
OLE Period (Up to 52 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
5
|
11
|
3
|
5
|
|
OLE Period (Up to 52 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
OLE Period (Up to 52 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
11
|
3
|
8
|
|
OLE Period (Up to 52 Weeks)
No longer met eligibility criteria
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
OLE Period (Up to 52 Weeks)
Adverse Event
|
0
|
0
|
0
|
7
|
13
|
4
|
15
|
Baseline Characteristics
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 10.64 • n=7 Participants
|
36.5 Years
STANDARD_DEVIATION 12.70 • n=5 Participants
|
35.6 Years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=71 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period
|
12.8 Percentage of participants
Interval 7.1 to 19.9
|
27.2 Percentage of participants
Interval 19.6 to 35.7
|
33.8 Percentage of participants
Interval 25.1 to 43.1
|
—
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: Safety analysis set (SAS) included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Pre-specified criteria for lab abnormalities included- hematology: hemoglobin(Hb), erythrocytes (ery),hematocrit:\<0.8\*lower limit of normal(LLN);reticulocytes: \<0.5\*LLN, \>1.5\*upper limit of normal(ULN); ery mean corpuscular(EMC) volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN,\>1.5\*ULN;lymphocyte,neutrophil(10\^9/L):\<0.8\*LLN,\>1.2\*ULN;basophil,eosinophil,monocyte(10\^9/L):\>1.2\*ULN;activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8;urine,glucose,protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=36 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=83 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=32 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=63 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities During OLE Period
|
33 Participants
|
76 Participants
|
26 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (millimeter of mercury \[mmHg\]), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and change \>= 30 (mmHg) decrease; PR: value \> 120 (beats per minute \[bpm\]).
Outcome measures
| Measure |
Induction Period: Placebo QD
n=36 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=83 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=32 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=63 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
DBP; value < 50 (mmHg)
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
DBP; change >=20 (mmHg) increase
|
4 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
DBP; change >=20 (mmHg) decrease
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
PR; value > 120 (bpm)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
SBP; value < 90 (mmHg)
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
SBP; change >= 30 (mmHg) increase
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants According to Categorization of Vital Signs During OLE Period
SBP; change >= 30 (mmHg) decrease
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc \>=480 milli second (msec) or an absolute change in QTc greater than (\>) 60 msec. Clinically significant ECG findings were determined by the investigator.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=23 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=50 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=21 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=40 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo).
An adverse event (AE) was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=36 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=84 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=32 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=64 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period
|
32 Participants
|
58 Participants
|
25 Participants
|
54 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo).
A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=36 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=84 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=32 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=64 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period
|
6 Participants
|
10 Participants
|
5 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo).
An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=36 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=84 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=32 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=64 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Discontinuations Due to Adverse Events During OLE Period
Discontinuation from study due to TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Discontinuations Due to Adverse Events During OLE Period
Permanent discontinuation from any study intervention due to TEAEs
|
7 Participants
|
13 Participants
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Pre-specified criteria for lab abnormalities included- hematology: hemoglobin, erythrocytes, hematocrit:\<0.8\*LLN; reticulocytes: \<0.5\*LLN, \>1.5\*ULN; EMC volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN, \>1.5\*ULN; lymphocyte, neutrophil(10\^9/L):\<0.8\*LLN, \>1.2\*ULN; basophil, eosinophil, monocyte(10\^9/L):\>1.2\*ULN; activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8; urine, glucose, protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities During Induction Period
|
67 Participants
|
72 Participants
|
61 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here, 'Number Analyzed' signifies number of participants evaluable for specific rows.
Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (mmHg), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and PR: value \> 120 (bpm).
Outcome measures
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Diastolic blood pressure; value < 50 (mmHg)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Diastolic blood pressure; change >=20 (mmHg) increase
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Diastolic blood pressure; change >=20 (mmHg) decrease
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Pulse rate; value > 120 (bpm)
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Systolic blood pressure; value < 90 (mmHg)
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Systolic blood pressure; change >= 30 (mmHg) increase
|
3 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Number of Participants According to Categorization of Vital Signs During Induction Period
Systolic blood pressure; change >= 30 (mmHg) decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc greater than or equal to (\>=)480 milli second (msec) or an absolute change in QTc greater than (\>)60 msec. Clinically significant ECG findings were determined by the investigator.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=68 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=83 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=63 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group.
An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period
|
51 Participants
|
46 Participants
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group.
A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period
|
6 Participants
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group.
An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants Discontinuation Due to Adverse Events During Induction Period
Discontinuations from study due to TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Discontinuation Due to Adverse Events During Induction Period
Permanent discontinuations from any study intervention due to TEAEs
|
6 Participants
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to Week 12Population: SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group.
Participants were monitored for development of any infection (viral, bacterial and fungal). Serious infections were treated infections that required parenteral antimicrobial therapy and were present with positive pre-treatment culture and required hospitalization for treatment/met other criteria that required the infection to be classified as SAE. An SAE was any untoward medical occurrence at any dose that: resulted in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity/results in congenital anomaly/birth defect. Treated infections were infections that required antimicrobial therapy by any route of administration/required any surgical intervention (e.g., incision and drainage).
Outcome measures
| Measure |
Induction Period: Placebo QD
n=79 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Number of Participants With Serious Infections During Induction Period
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
CMEI was defined as reduction of \>=3 points from baseline in SES-CD score as assessed by centrally read SES-CD score. Baseline: last measurement prior to first dosing on Day1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for 4 domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5cm),2=Large ulcer(0.5-2cm),3=very large ulcer(\>2cm); ulcerated surface score: 0=none,1=\<10%,2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=71 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period
|
29.5 Percentage of participants
Interval 21.7 to 38.9
|
42.4 Percentage of participants
Interval 34.2 to 51.5
|
57.7 Percentage of participants
Interval 47.6 to 67.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Mean change from baseline in SES-CD score at Week 12 analyzed using analysis of covariance(ANCOVA)model with treatment,baseline disease activity/extent as factors, baseline SES CD score as covariate. Baseline=last measurement prior to first dosing on Day 1. Following bowel segments used for calculating SES-CD scores: Ileum,right C,transverse C,left C,rectum. Each segment assessed for four domains:presence of ulcers, ulcerated surface, affected surface,presence of narrowing, each score on a scale of 0-3,higher scores=more severe condition. Presence of ulcers score:0=none,1=small ulcer:(0.1-0.5cm),2=large ulcer(0.5-2cm),3=very large ulcer(\>2 cm);ulcerated surface score:0=none,1=\<10%,2=10-30%,3=\>30%;affected surface score:0=unaffected segment,1=\<50%, 2=50-75%,3=\>75%;presence of narrowing score:0=none,1=single,can be passed,2=multiple can be passed,3=cannot be passed. Total SES CD score=sum of each domain score for all 5 bowel segments,range from 0 to 60,higher score =more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=68 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=82 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=63 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in SES-CD Score at Week 12: Induction Period
|
-0.1 Units on a scale
Interval -1.32 to 1.12
|
-3.1 Units on a scale
Interval -4.22 to -2.02
|
-5.0 Units on a scale
Interval -6.36 to -3.72
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
SES CD25 was defined as \>=25% improvement from baseline in SES CD. Baseline was defined as the last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=71 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period
|
25.6 Percentage of participants
Interval 17.7 to 34.3
|
39.1 Percentage of participants
Interval 30.6 to 47.4
|
56.3 Percentage of participants
Interval 46.2 to 66.4
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Endoscopic remission was defined as SES-CD score of \<= 2. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=71 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period
|
5.1 Percentage of participants
Interval 2.3 to 11.2
|
7.6 Percentage of participants
Interval 4.0 to 13.2
|
12.7 Percentage of participants
Interval 7.2 to 20.8
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Mucosal healing was defined as complete absence of ulcers.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=78 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=92 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=71 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period
|
5.1 Percentage of participants
Interval 2.3 to 11.2
|
10.9 Percentage of participants
Interval 6.1 to 17.7
|
16.9 Percentage of participants
Interval 10.1 to 25.8
|
—
|
SECONDARY outcome
Timeframe: Week 64 (Week 52 of OLE period)Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
CMEI was defined as reduction of \>=3 points from baseline as assessed by centrally read SES CD score. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5 cm),2=Large ulcer(0.5-2 cm),3=very large ulcer(\>2 cm); ulcerated surface score: 0=none,1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0-60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=11 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=34 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=11 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=38 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period
|
27.3 Percentage of participants
Interval 10.5 to 56.4
|
44.1 Percentage of participants
Interval 30.7 to 59.5
|
54.5 Percentage of participants
Interval 30.2 to 80.0
|
42.1 Percentage of participants
Interval 28.5 to 56.7
|
SECONDARY outcome
Timeframe: Week 64 (Week 52 of OLE period)Population: FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed"=participants evaluable for specified rows.
SES CD50 and SES CD25: 50% and 25% improvement from baseline, respectively. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 cm), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Outcome measures
| Measure |
Induction Period: Placebo QD
n=8 Participants
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=31 Participants
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=11 Participants
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=38 Participants
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SES CD 25 and SES CD 50 at Week 64 Among Participants Who Achieved SES CD 25 and SES CD 50 at Week 12 (Baseline of OLE Period): OLE Period
SES-CD 25
|
25.0 Percentage of participants
Interval 6.9 to 58.2
|
41.9 Percentage of participants
Interval 26.9 to 57.9
|
54.5 Percentage of participants
Interval 30.2 to 80.0
|
42.1 Percentage of participants
Interval 28.5 to 56.7
|
|
Percentage of Participants Achieving SES CD 25 and SES CD 50 at Week 64 Among Participants Who Achieved SES CD 25 and SES CD 50 at Week 12 (Baseline of OLE Period): OLE Period
SES-CD 50
|
25.0 Percentage of participants
Interval 2.6 to 68.0
|
36.4 Percentage of participants
Interval 19.6 to 55.6
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
36.4 Percentage of participants
Interval 19.6 to 55.6
|
Adverse Events
Induction Period: Placebo QD
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Induction Period: Ritlecitinib 200 mg/50 mg QD
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Induction Period: Brepocitinib 60 mg QD
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
OLE Period: Placebo QD -> Ritlecitinib 50 mg QD
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
OLE Period: Placebo QD -> Brepocitinib 30 mg QD
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
Serious events: 16 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Period: Placebo QD
n=79 participants at risk
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 participants at risk
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 participants at risk
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Placebo QD -> Ritlecitinib 50 mg QD
n=36 participants at risk
Participants who received placebo matched to ritlecitinib during the induction period were administered ritlecitinib 50 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD
n=84 participants at risk
Participants who received ritlecitinib 200 mg /50 mg QD in the induction period were administered ritlecitinib 50 mg QD for 52 weeks in OLE period.
|
OLE Period: Placebo QD -> Brepocitinib 30 mg QD
n=32 participants at risk
Participants who received placebo matched to brepocitinib in the induction period were administered brepocitinib 30 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=64 participants at risk
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
6.3%
5/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.2%
2/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.0%
5/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
9.4%
3/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.9%
7/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.1%
1/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.1%
1/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.4%
1/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.1%
1/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.4%
1/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Mesenteric abscess
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.4%
1/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.4%
1/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
Other adverse events
| Measure |
Induction Period: Placebo QD
n=79 participants at risk
Participants received placebo matched to either PF-06651600 (ritlecitinib) or PF-06700841 (brepocitinib) QD orally for 12 weeks in induction period.
|
Induction Period: Ritlecitinib 200 mg/50 mg QD
n=93 participants at risk
Participants received PF-06651600 (ritlecitinib) 200 mg QD orally for 8 weeks followed by ritlecitinib 50 mg QD orally for 4 weeks in induction period.
|
Induction Period: Brepocitinib 60 mg QD
n=72 participants at risk
Participants received PF-06700841 (brepocitinib) 60 mg QD orally for 12 weeks in induction period.
|
OLE Period: Placebo QD -> Ritlecitinib 50 mg QD
n=36 participants at risk
Participants who received placebo matched to ritlecitinib during the induction period were administered ritlecitinib 50 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD
n=84 participants at risk
Participants who received ritlecitinib 200 mg /50 mg QD in the induction period were administered ritlecitinib 50 mg QD for 52 weeks in OLE period.
|
OLE Period: Placebo QD -> Brepocitinib 30 mg QD
n=32 participants at risk
Participants who received placebo matched to brepocitinib in the induction period were administered brepocitinib 30 mg QD orally for 52 weeks in OLE period.
|
OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD
n=64 participants at risk
Participants who received brepocitinib 60 mg QD in the induction period were administered brepocitinib 30 mg QD for 52 weeks in OLE period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
2/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.3%
1/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.2%
3/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
4/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.2%
2/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
4/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
4/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.0%
5/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
4/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
9.4%
6/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
5.1%
4/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.2%
2/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
2/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
4/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.7%
9/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
4/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.6%
3/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.4%
2/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.4%
2/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
4.7%
3/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.4%
2/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.6%
3/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
4/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.2%
2/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.6%
3/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
2/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
3.8%
3/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.5%
6/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.4%
1/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
6/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
4.8%
4/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
4/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
8/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
4/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.2%
3/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
2/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
4/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.4%
2/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
5.1%
4/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.2%
3/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.9%
5/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
2/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
4/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
2/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
3/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.1%
1/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
4/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
4/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.2%
1/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
1/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
3.1%
2/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
2.8%
1/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
2/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
4.7%
3/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/79 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/93 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/72 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
5.6%
2/36 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/84 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/32 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
1.6%
1/64 • Induction Period: From start of study intervention on Day 1 up to Week 12 (for a maximum duration of 12 weeks); OLE Period: From start of study intervention in OLE period (Week 12) up to 4 weeks after last dose of study intervention on Week 64 (for a maximum duration of 56 weeks)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER