Trial Outcomes & Findings for A Study of PRN1008 in Patients With Pemphigus (NCT NCT03762265)
NCT ID: NCT03762265
Last Updated: 2023-08-02
Results Overview
Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of \<=10 mg/day were reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
From Week 29 to Week 37
Results posted on
2023-08-02
Participant Flow
Study was conducted at 88 active sites in 19 countries. A total of 210 participants were screened from 08 January 2019 to 23 October 2020, of whom 79 participants were screen failures, mainly due to not meeting inclusion criteria. A total of 131 participants were enrolled and randomized in the study, consisted of 3 parts: blinded treatment (BT) period (Baseline to Week 37), open-label extension (OLE) period (Week 37 to Week 61) and long term extension (LTE) Period (Week 61 to Week 109).
Participants with moderate to severe pemphigus (pemphigus vulgaris \[PV\] and pemphigus foliaceus \[PF\]) were randomized (1:1 ratio) to receive either rilzabrutinib or placebo in BT period.
Participant milestones
| Measure |
Placebo Then Rilzabrutinib
In BT period, participants received placebo orally twice daily (BID) up to 37 weeks along with sponsor-provided corticosteroids (CS). After at least two weeks of control of disease activity (CDA; no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 milligrams (mg) prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
|---|---|---|
|
BT Period: Weeks 1 to 37
STARTED
|
66
|
65
|
|
BT Period: Weeks 1 to 37
COMPLETED
|
51
|
62
|
|
BT Period: Weeks 1 to 37
NOT COMPLETED
|
15
|
3
|
|
OLE Period: Weeks 37 to 61
STARTED
|
51
|
61
|
|
OLE Period: Weeks 37 to 61
COMPLETED
|
35
|
45
|
|
OLE Period: Weeks 37 to 61
NOT COMPLETED
|
16
|
16
|
|
LTE Period: Weeks 61 to 109
STARTED
|
35
|
34
|
|
LTE Period: Weeks 61 to 109
COMPLETED
|
6
|
6
|
|
LTE Period: Weeks 61 to 109
NOT COMPLETED
|
29
|
28
|
Reasons for withdrawal
| Measure |
Placebo Then Rilzabrutinib
In BT period, participants received placebo orally twice daily (BID) up to 37 weeks along with sponsor-provided corticosteroids (CS). After at least two weeks of control of disease activity (CDA; no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 milligrams (mg) prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
|---|---|---|
|
BT Period: Weeks 1 to 37
Adverse Event
|
7
|
2
|
|
BT Period: Weeks 1 to 37
Lack of Efficacy
|
1
|
0
|
|
BT Period: Weeks 1 to 37
Physician Decision
|
1
|
0
|
|
BT Period: Weeks 1 to 37
Required prohibited medication
|
2
|
0
|
|
BT Period: Weeks 1 to 37
Withdrawal by Subject
|
4
|
0
|
|
BT Period: Weeks 1 to 37
Other
|
0
|
1
|
|
OLE Period: Weeks 37 to 61
Adverse Event
|
1
|
2
|
|
OLE Period: Weeks 37 to 61
Lack of Efficacy
|
3
|
2
|
|
OLE Period: Weeks 37 to 61
Non-compliance with study drug
|
1
|
0
|
|
OLE Period: Weeks 37 to 61
Study terminated by sponsor
|
8
|
10
|
|
OLE Period: Weeks 37 to 61
Withdrawal by Subject
|
3
|
2
|
|
LTE Period: Weeks 61 to 109
Lack of Efficacy
|
0
|
1
|
|
LTE Period: Weeks 61 to 109
Study terminated by sponsor
|
28
|
25
|
|
LTE Period: Weeks 61 to 109
Withdrawal by Subject
|
0
|
2
|
|
LTE Period: Weeks 61 to 109
Other
|
1
|
0
|
Baseline Characteristics
A Study of PRN1008 in Patients With Pemphigus
Baseline characteristics by cohort
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 14.00 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on PV mITT which included randomized PV participants who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.
Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of \<=10 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population
|
18.2 percentage of participants
|
24.1 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on mITT population which included all randomized participants (i.e. PV + PF participants) who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.
Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with PDAI activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=10 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population
|
18.2 percentage of participants
|
26.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on PV mITT population.
The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population
|
5653.2 milligrams
Standard Deviation 3155.97
|
5131.4 milligrams
Standard Deviation 2623.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on mITT population.
The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population
|
5392.2 milligrams
Standard Deviation 2993.02
|
4860.2 milligrams
Standard Deviation 2545.32
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on PV mITT population.
Cumulative duration (in days) of CR post first CS dose of \<= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population
|
34.1 days
Standard Deviation 51.58
|
50.5 days
Standard Deviation 67.10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on mITT population.
Cumulative duration (in days) of CR post first CS dose of \<= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population
|
34.0 days
Standard Deviation 54.36
|
54.3 days
Standard Deviation 68.76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on PV mITT population.
Time to first CR was the time (in days) to achieve CR while on CS dose of \<=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population
|
252.0 days
Interval 150.0 to
Upper limit of 95% CI was not estimable due to low number of participants with events.
|
197.0 days
Interval 156.0 to
Upper limit of 95% CI was not estimable due to very low number of participants with events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 37Population: Analysis was performed on mITT population.
Time to first CR was the time (in days) to achieve CR while on CS dose of \<=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population
|
NA days
Median, upper and lower limit of 95% CI was not estimable due to low number of participants with events.
|
197.0 days
Interval 142.0 to
Upper limit of 95% CI was not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on PV mITT population.
Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=5 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: PV mITT Population
|
10.9 percentage of participants
|
24.1 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on mITT population.
Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=5 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: mITT Population
|
12.1 percentage of participants
|
26.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on PV mITT population.
PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score \<3 while on a CS dose of \<=10 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had Pemphigus Disease Area Index (PDAI) Score <3 With a Corticosteroids Dose <=10 mg/Day From Week 29 to Week 37: PV mITT Population
|
29.1 percentage of participants
|
35.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 29 to Week 37Population: Analysis was performed on mITT population.
PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score \<3 while on a CS dose of \<=10 mg/day were reported.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had Pemphigus Disease Area Index Score <3 With a Corticosteroids Dose <=10 mg/Day From Week 29 to Week 37: mITT Population
|
27.3 percentage of participants
|
38.5 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 61 and Baseline to Week 109Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.
Cumulative duration (in days) of CR post all doses of CS \<=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
Baseline to Week 61
|
73.8 days
Standard Deviation 95.35
|
112.2 days
Standard Deviation 120.65
|
—
|
—
|
—
|
—
|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
Baseline to Week 109
|
102.2 days
Standard Deviation 133.22
|
157.0 days
Standard Deviation 179.71
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 61 and Baseline to Week 109Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.
Cumulative duration (in days) of CR post all doses of CS \<=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population
Baseline to Week 61
|
78.1 days
Standard Deviation 98.68
|
120.4 days
Standard Deviation 124.38
|
—
|
—
|
—
|
—
|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population
Baseline to Week 109
|
124.6 days
Standard Deviation 153.76
|
171.6 days
Standard Deviation 186.66
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 61 and Baseline to Week 109Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.
Cumulative duration (in days) of CR post all doses of CS =0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
Baseline to Week 61
|
13.5 days
Standard Deviation 35.33
|
28.6 days
Standard Deviation 52.33
|
—
|
—
|
—
|
—
|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
Baseline to Week 109
|
28.4 days
Standard Deviation 77.54
|
60.7 days
Standard Deviation 118.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 61 and Baseline to Week 109Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.
Cumulative duration (in days) of CR post all doses of CS dose = 0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population
Baseline to Week 109
|
49.5 days
Standard Deviation 106.14
|
72.5 days
Standard Deviation 125.60
|
—
|
—
|
—
|
—
|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population
Baseline to Week 61
|
17.6 days
Standard Deviation 38.56
|
33.5 days
Standard Deviation 55.06
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 37Population: Analysis was performed on PV mITT population.
GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI had 9 domains and specific list had 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score:sum of 9 domain-specific scores at each visit and cumulative GTI score:sum of composite GTI scores across each visit. 2 cumulative GTI scores: CWS and AIS at Week 37 reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score range: 0 to 439 and AIS composite score range: -346 to 439. In CWS and AIS, minimum score=least toxicity and maximum score=most toxicity. Least square (LS) mean and standard error (SE) from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population
CWS
|
54.46 units on a scale
Standard Error 8.136
|
73.60 units on a scale
Standard Error 7.397
|
—
|
—
|
—
|
—
|
|
Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population
AIS
|
9.42 units on a scale
Standard Error 6.516
|
19.95 units on a scale
Standard Error 5.924
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 37Population: Analysis was performed on mITT population.
GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI contained 9 domains and specific list contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score: sum of 9 domain-specific scores at each visit and cumulative GTI score: sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 37 were reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score ranged from 0 to 439 and AIS composite score ranged from -346 to 439. For CWS and AIS, minimum score = least toxicity and maximum score = most toxicity. LS mean and SE from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population
CWS
|
51.68 units on a scale
Standard Error 7.368
|
68.15 units on a scale
Standard Error 6.732
|
—
|
—
|
—
|
—
|
|
Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population
AIS
|
8.63 units on a scale
Standard Error 5.730
|
18.23 units on a scale
Standard Error 5.236
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.
PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 5
|
-7.567 units on a scale
Standard Deviation 12.6310
|
-7.224 units on a scale
Standard Deviation 6.9832
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 13
|
-11.076 units on a scale
Standard Deviation 11.4549
|
-13.925 units on a scale
Standard Deviation 10.1497
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 25
|
-11.333 units on a scale
Standard Deviation 13.8064
|
-15.292 units on a scale
Standard Deviation 10.5552
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 37
|
-13.000 units on a scale
Standard Deviation 10.9202
|
-14.167 units on a scale
Standard Deviation 9.8679
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 61
|
-12.900 units on a scale
Standard Deviation 6.6418
|
-16.475 units on a scale
Standard Deviation 10.1585
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 109
|
-21.300 units on a scale
|
-18.250 units on a scale
Standard Deviation 9.8288
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.
PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 5
|
-7.870 units on a scale
Standard Deviation 12.5361
|
-7.161 units on a scale
Standard Deviation 6.5918
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 13
|
-11.253 units on a scale
Standard Deviation 12.1328
|
-13.139 units on a scale
Standard Deviation 10.3317
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 25
|
-11.722 units on a scale
Standard Deviation 13.2580
|
-14.174 units on a scale
Standard Deviation 11.1997
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 37
|
-12.918 units on a scale
Standard Deviation 11.0260
|
-13.442 units on a scale
Standard Deviation 10.2669
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 61
|
-13.793 units on a scale
Standard Deviation 8.9794
|
-14.649 units on a scale
Standard Deviation 11.4991
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 109
|
-23.967 units on a scale
Standard Deviation 16.4628
|
-18.250 units on a scale
Standard Deviation 9.8288
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=52 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=51 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 5
|
-2.20 score on a scale
Standard Deviation 6.856
|
-4.47 score on a scale
Standard Deviation 7.668
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 13
|
-4.04 score on a scale
Standard Deviation 6.831
|
-6.22 score on a scale
Standard Deviation 7.218
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 25
|
-5.88 score on a scale
Standard Deviation 7.443
|
-8.32 score on a scale
Standard Deviation 7.647
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 37
|
-4.53 score on a scale
Standard Deviation 7.518
|
-7.19 score on a scale
Standard Deviation 8.187
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 61
|
-7.76 score on a scale
Standard Deviation 6.389
|
-8.64 score on a scale
Standard Deviation 10.140
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 109
|
-19.00 score on a scale
|
-19.50 score on a scale
Standard Deviation 6.364
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=63 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=62 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 5
|
-2.02 score on a scale
Standard Deviation 6.474
|
-4.50 score on a scale
Standard Deviation 7.324
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 13
|
-3.18 score on a scale
Standard Deviation 7.262
|
-5.93 score on a scale
Standard Deviation 7.168
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 25
|
-5.23 score on a scale
Standard Deviation 7.259
|
-7.57 score on a scale
Standard Deviation 7.667
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 37
|
-4.43 score on a scale
Standard Deviation 7.150
|
-7.00 score on a scale
Standard Deviation 7.843
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 61
|
-7.40 score on a scale
Standard Deviation 7.416
|
-7.47 score on a scale
Standard Deviation 9.263
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 109
|
-13.00 score on a scale
Standard Deviation 6.000
|
-19.50 score on a scale
Standard Deviation 6.364
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.
ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 5
|
0.0 percentage of participants
|
2.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 13
|
2.1 percentage of participants
|
4.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 25
|
4.4 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 37
|
7.9 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 61
|
11.8 percentage of participants
|
12.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
Week 109
|
0.0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 5, 13, 25, 37, 61, and 109Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.
ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 5
|
0.0 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 13
|
1.8 percentage of participants
|
5.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 25
|
3.7 percentage of participants
|
6.8 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 37
|
6.4 percentage of participants
|
5.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 61
|
12.0 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
Week 109
|
33.3 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: For this OM, the planned data collection and analysis was not performed because of early termination of the study.
EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0 to 100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, 25, 37, 61, and 109Population: For this OM, the planned data collection and analysis was not performed because of early termination of the study.
EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 61 and Baseline to Week 109Population: For this OM, the planned data collection and analysis was not performed because of early termination of the study.
Time to first CR was the time (in days) to achieve CR while on a CS dose of \<=10 mg/day from Baseline to Week 61 and from Baseline to Week 109. Complete remission was defined as absence of new and established lesions to the "no disease activity".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=51 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=53 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Total Number of Disease Relapses/Flares From Initial Control of Disease Activity (CDA) to Week 37: PV mITT Population
|
0.6 relapses
Standard Deviation 0.96
|
0.3 relapses
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=62 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=64 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Total Number of Disease Relapses/Flares From Initial Control of Disease Activity to Week 37: mITT Population
|
0.6 relapses
Standard Deviation 0.94
|
0.3 relapses
Standard Deviation 0.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=51 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=53 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population
|
243.0 days
Interval 144.0 to
Upper limit of 95% CI was not estimable due to low number of participants with the events.
|
NA days
Median, upper and lower limit of 95% CI were not estimable due to low number of participants with the events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=62 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=64 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population
|
243.0 days
Interval 148.0 to
Upper limit of 95% CI was not estimable due to low number of participants with the events.
|
NA days
Median, upper and lower limit of 95% CI were not estimable due to low number of participants with the events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 37Population: Analysis was performed on PV mITT population.
Percentage of Participants With 3 or More New Lesions Within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: PV mITT Population
|
58.2 percentage of participants
|
35.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 37Population: Analysis was performed on mITT population.
Percentage of participants with 3 or more new lesions within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: mITT Population
|
59.1 percentage of participants
|
36.9 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on PV mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=51 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=53 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population
|
43.1 percentage of participants
|
28.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=62 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=64 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population
|
43.5 percentage of participants
|
29.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 37 to Week 61Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Cumulative duration (in days) of CR post first dose of CS \<=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=42 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=50 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Week 37 to Week 61: PV mITT Population
|
52.0 days
Standard Deviation 59.01
|
62.5 days
Standard Deviation 67.59
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 37 to Week 61Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Cumulative duration (in days) of CR post first dose of CS \<=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=51 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=61 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Week 37 to Week 61: mITT Population
|
57.1 days
Standard Deviation 59.99
|
67.1 days
Standard Deviation 68.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 37 to Week 61Population: Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=42 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=50 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: PV mITT Population
|
17.7 days
Standard Deviation 39.60
|
30.5 days
Standard Deviation 53.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 37 to Week 61Population: Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=51 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=61 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: mITT Population
|
22.8 days
Standard Deviation 42.58
|
35.3 days
Standard Deviation 56.32
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)Population: Analysis was performed on safety population which included all participants who had received at least one dose of study medication and were analyzed according to the treatment they actually received.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious after the administration of first dose of study drug in each period.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
n=51 Participants
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
n=61 Participants
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
n=35 Participants
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
n=34 Participants
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAE
|
54 Participants
|
55 Participants
|
33 Participants
|
35 Participants
|
18 Participants
|
14 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAE
|
10 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose on Day 1Population: Analysis was performed on PK population which included all participants who had received at least one dose of study medication and had sufficient data for PK analysis.
Data for this OM was not planned to be collected and analyzed for placebo arm of the study.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=65 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib
Day 1: 2-hour post-dose
|
273.13 nanograms per milliliter
Standard Deviation 264.136
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib
Day 1: pre-dose
|
NA nanograms per milliliter
Standard Deviation NA
Pre-dose concentration was below limit of quantification (0.1 nanogram per milliliter) and thus mean and standard deviation data were not calculable.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109Population: Analysis was performed on PV mITT population. Here, 'number analyzed' = participants with available data for each specified category.
Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by enzyme-linked immunosorbent assay (ELISA) method.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=55 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=54 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Baseline: Anti-dsg1
|
108.4 units/milliliter
Standard Deviation 288.97
|
85.9 units/milliliter
Standard Deviation 139.17
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Baseline: Anti-dsg3
|
392.5 units/milliliter
Standard Deviation 697.52
|
464.1 units/milliliter
Standard Deviation 668.22
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 13: Anti-dsg1
|
60.6 units/milliliter
Standard Deviation 116.32
|
15.4 units/milliliter
Standard Deviation 34.20
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 13: Anti-dsg3
|
197.1 units/milliliter
Standard Deviation 320.37
|
99.8 units/milliliter
Standard Deviation 146.65
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 25: Anti-dsg1
|
48.2 units/milliliter
Standard Deviation 93.15
|
17.5 units/milliliter
Standard Deviation 37.44
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 25: Anti-dsg3
|
218.6 units/milliliter
Standard Deviation 314.74
|
153.7 units/milliliter
Standard Deviation 351.56
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 37: Anti-dsg1
|
42.0 units/milliliter
Standard Deviation 95.02
|
24.1 units/milliliter
Standard Deviation 60.01
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 37: Anti-dsg3
|
204.4 units/milliliter
Standard Deviation 313.26
|
213.9 units/milliliter
Standard Deviation 389.85
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 49: Anti-dsg1
|
12.1 units/milliliter
Standard Deviation 18.66
|
17.1 units/milliliter
Standard Deviation 31.99
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 49: Anti-dsg3
|
215.6 units/milliliter
Standard Deviation 327.22
|
277.1 units/milliliter
Standard Deviation 575.77
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 61: Anti-dsg1
|
12.0 units/milliliter
Standard Deviation 20.61
|
12.5 units/milliliter
Standard Deviation 26.08
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 61: Anti-dsg3
|
252.3 units/milliliter
Standard Deviation 439.45
|
223.5 units/milliliter
Standard Deviation 271.69
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 73: Anti-dsg1
|
12.8 units/milliliter
Standard Deviation 23.21
|
10.5 units/milliliter
Standard Deviation 26.34
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 73: Anti-dsg3
|
237.1 units/milliliter
Standard Deviation 412.33
|
157.6 units/milliliter
Standard Deviation 186.82
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 85: Anti-dsg1
|
11.7 units/milliliter
Standard Deviation 24.31
|
14.2 units/milliliter
Standard Deviation 28.05
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 85: Anti-dsg3
|
169.9 units/milliliter
Standard Deviation 349.29
|
132.4 units/milliliter
Standard Deviation 189.76
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 97: Anti-dsg1
|
3.6 units/milliliter
Standard Deviation 5.27
|
4.7 units/milliliter
Standard Deviation 8.60
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 97: Anti-dsg3
|
193.0 units/milliliter
Standard Deviation 330.12
|
95.4 units/milliliter
Standard Deviation 180.66
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 109: Anti-dsg1
|
1.0 units/milliliter
|
2.0 units/milliliter
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
Change at Week 109: Anti-dsg3
|
0.0 units/milliliter
|
94.0 units/milliliter
Standard Deviation 115.97
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category.
Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by ELISA method.
Outcome measures
| Measure |
Placebo Then Rilzabrutinib
n=66 Participants
In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.
|
Rilzabrutinib Then Rilzabrutinib
n=65 Participants
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
|
OLE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 109: Anti-dsg1
|
4.7 units/milliliter
Standard Deviation 4.73
|
2.0 units/milliliter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Baseline: Anti-dsg1
|
132.2 units/milliliter
Standard Deviation 275.92
|
141.7 units/milliliter
Standard Deviation 366.74
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Baseline: Anti-dsg3
|
328.8 units/milliliter
Standard Deviation 651.84
|
385.8 units/milliliter
Standard Deviation 632.71
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 13: Anti-dsg1
|
73.7 units/milliliter
Standard Deviation 116.08
|
39.8 units/milliliter
Standard Deviation 102.35
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 13: Anti-dsg3
|
166.1 units/milliliter
Standard Deviation 302.25
|
82.5 units/milliliter
Standard Deviation 138.29
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 25: Anti-dsg1
|
65.6 units/milliliter
Standard Deviation 105.99
|
40.5 units/milliliter
Standard Deviation 106.10
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 25: Anti-dsg3
|
182.4 units/milliliter
Standard Deviation 298.18
|
124.3 units/milliliter
Standard Deviation 320.96
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 37: Anti-dsg1
|
59.5 units/milliliter
Standard Deviation 101.58
|
37.0 units/milliliter
Standard Deviation 68.28
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 37: Anti-dsg3
|
167.8 units/milliliter
Standard Deviation 293.78
|
176.5 units/milliliter
Standard Deviation 362.67
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 49: Anti-dsg1
|
31.9 units/milliliter
Standard Deviation 53.27
|
44.1 units/milliliter
Standard Deviation 102.07
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 49: Anti-dsg3
|
163.4 units/milliliter
Standard Deviation 298.38
|
216.4 units/milliliter
Standard Deviation 520.01
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 61: Anti-dsg1
|
41.5 units/milliliter
Standard Deviation 68.66
|
44.6 units/milliliter
Standard Deviation 88.74
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 61: Anti-dsg3
|
165.3 units/milliliter
Standard Deviation 372.10
|
159.2 units/milliliter
Standard Deviation 249.62
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 73: Anti-dsg1
|
43.5 units/milliliter
Standard Deviation 87.58
|
48.5 units/milliliter
Standard Deviation 139.91
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 73: Anti-dsg3
|
165.2 units/milliliter
Standard Deviation 358.15
|
112.0 units/milliliter
Standard Deviation 171.90
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 85: Anti-dsg1
|
22.3 units/milliliter
Standard Deviation 39.62
|
42.1 units/milliliter
Standard Deviation 105.90
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 85: Anti-dsg3
|
116.9 units/milliliter
Standard Deviation 296.51
|
97.9 units/milliliter
Standard Deviation 170.97
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 97: Anti-dsg1
|
21.9 units/milliliter
Standard Deviation 46.36
|
52.2 units/milliliter
Standard Deviation 141.86
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 97: Anti-dsg3
|
107.6 units/milliliter
Standard Deviation 254.47
|
76.0 units/milliliter
Standard Deviation 161.13
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
Change at Week 109: Anti-dsg3
|
1.0 units/milliliter
Standard Deviation 1.73
|
94.0 units/milliliter
Standard Deviation 115.97
|
—
|
—
|
—
|
—
|
Adverse Events
BT Period: Placebo
Serious events: 10 serious events
Other events: 41 other events
Deaths: 2 deaths
BT Period: Rilzabrutinib
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
OLE Period: Placebo Then Rilzabrutinib
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
OLE Period: Rilzabrutinib Then Rilzabrutinib
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
OLE Period: Overall (All Participants)
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
LTE Period: Placebo Then Rilzabrutinib
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
LTE Period: Rilzabrutinib Then Rilzabrutinib
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
LTE Period: Overall (All Participants)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BT Period: Placebo
n=66 participants at risk
Participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.
|
BT Period: Rilzabrutinib
n=65 participants at risk
Participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with Sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone per day from Week 29 to Week 37.
|
OLE Period: Placebo Then Rilzabrutinib
n=51 participants at risk
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
n=61 participants at risk
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Overall (All Participants)
n=112 participants at risk
All eligible participants post completion of BT period (after receiving placebo/rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
n=35 participants at risk
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
n=34 participants at risk
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Overall (All Participants)
n=69 participants at risk
All eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
3.0%
2/66 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Covid-19 Pneumonia
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Meningitis Bacterial
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Metabolism and nutrition disorders
Steroid Diabetes
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Psychiatric disorders
Mania
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Eye disorders
Vogt-Koyanagi-Harada Disease
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Cardiac disorders
Atrial Flutter
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Vascular disorders
Embolism Arterial
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
3.0%
2/66 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
General disorders
Pyrexia
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
Other adverse events
| Measure |
BT Period: Placebo
n=66 participants at risk
Participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.
|
BT Period: Rilzabrutinib
n=65 participants at risk
Participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with Sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone per day from Week 29 to Week 37.
|
OLE Period: Placebo Then Rilzabrutinib
n=51 participants at risk
Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Rilzabrutinib Then Rilzabrutinib
n=61 participants at risk
Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
OLE Period: Overall (All Participants)
n=112 participants at risk
All eligible participants post completion of BT period (after receiving placebo/rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.
|
LTE Period: Placebo Then Rilzabrutinib
n=35 participants at risk
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Rilzabrutinib Then Rilzabrutinib
n=34 participants at risk
Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
LTE Period: Overall (All Participants)
n=69 participants at risk
All eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.9%
2/34 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Oral Herpes
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.6%
3/65 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.9%
2/34 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Tinea Versicolour
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.8%
2/112 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.7%
2/35 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
7.7%
5/65 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Blood and lymphatic system disorders
Increased Tendency To Bruise
|
10.6%
7/66 • Number of events 8 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
24.6%
16/65 • Number of events 17 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.9%
2/51 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.9%
3/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.5%
5/112 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Endocrine disorders
Cushingoid
|
7.6%
5/66 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Psychiatric disorders
Depression
|
9.1%
6/66 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
16.9%
11/65 • Number of events 14 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Psychiatric disorders
Insomnia
|
9.1%
6/66 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
18.5%
12/65 • Number of events 14 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.9%
2/51 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Psychiatric disorders
Mania
|
4.5%
3/66 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
9.2%
6/65 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Nervous system disorders
Cognitive Disorder
|
6.1%
4/66 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
9.2%
6/65 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
6.2%
4/65 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.9%
2/51 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.8%
2/112 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Nervous system disorders
Headache
|
7.6%
5/66 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
13.8%
9/65 • Number of events 14 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.9%
2/51 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.9%
3/61 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.5%
5/112 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Eye disorders
Vision Blurred
|
6.1%
4/66 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Vascular disorders
Hypertension
|
10.6%
7/66 • Number of events 8 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
7.7%
5/65 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.8%
2/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.1%
6/66 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/65 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.8%
2/112 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.7%
2/35 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.1%
4/66 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
6.2%
4/65 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.9%
3/51 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/66 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
7.7%
5/65 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
7/66 • Number of events 8 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
12.3%
8/65 • Number of events 9 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
7.8%
4/51 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.9%
3/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
6.2%
7/112 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
6.2%
4/65 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/66 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
12.3%
8/65 • Number of events 12 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
15.7%
8/51 • Number of events 8 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
8.9%
10/112 • Number of events 10 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
4.5%
3/66 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
13.8%
9/65 • Number of events 10 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
5.7%
2/35 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
2/69 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
1.5%
1/66 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
9.2%
6/65 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
3/66 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.5%
1/65 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.9%
3/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
8.6%
3/35 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.3%
3/69 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Skin and subcutaneous tissue disorders
Skin Striae
|
1.5%
1/66 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
9.2%
6/65 • Number of events 8 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.8%
2/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
4/66 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.1%
2/65 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.9%
2/51 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.9%
3/61 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
4.5%
5/112 • Number of events 6 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
15.2%
10/66 • Number of events 11 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
23.1%
15/65 • Number of events 16 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.3%
2/61 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.7%
3/112 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/34 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
General disorders
Fatigue
|
7.6%
5/66 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.1%
2/65 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/112 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
General disorders
Oedema Peripheral
|
6.1%
4/66 • Number of events 7 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.1%
2/65 • Number of events 2 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/66 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
6.2%
4/65 • Number of events 4 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.0%
1/51 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/61 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
2.9%
1/35 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.4%
1/69 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
|
Investigations
Weight Increased
|
7.6%
5/66 • Number of events 5 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
3.1%
2/65 • Number of events 3 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/51 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
1.6%
1/61 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.89%
1/112 • Number of events 1 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/35 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/34 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
0.00%
0/69 • BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER