Trial Outcomes & Findings for Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy (NCT NCT04908475)
NCT ID: NCT04908475
Last Updated: 2024-04-30
Results Overview
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
352 participants
Primary outcome timeframe
Week 16
Results posted on
2024-04-30
Participant Flow
A total of 352 participants were enrolled from 48 sites across 5 countries including Canada, Germany, Israel, Poland, and the United States.
Period A: participants were randomized in a 1:2 ratio to risankizumab (RZB) or apremilast (APR). Period B: participants receiving RZB were continued up to Week 52; participants receiving APR were re-randomized in a 1:1 ratio to receive either RZB or APR (with the option to receive RZB as rescue) up to Week 52. Rerandomization was stratified by Psoriasis Area and Severity Index (PASI) 75 response (responder, non-responder) at Week 16.
Participant milestones
| Measure |
Period A: APR
Apremilast 30 mg orally twice daily (BID) up to Week 16
|
Periods A/B: RZB/RZB
Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
|
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders \[NR\]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
|
Period B: APR/APR, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders \[R\]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
|
|---|---|---|---|---|---|---|
|
Period A (Baseline to Week 16)
STARTED
|
234
|
118
|
0
|
0
|
0
|
0
|
|
Period A (Baseline to Week 16)
COMPLETED
|
216
|
118
|
0
|
0
|
0
|
0
|
|
Period A (Baseline to Week 16)
NOT COMPLETED
|
18
|
0
|
0
|
0
|
0
|
0
|
|
Period B (Week 16 to Week 52)
STARTED
|
0
|
118
|
78
|
83
|
22
|
20
|
|
Period B (Week 16 to Week 52)
Received ≥ 1 Dose of Study Drug
|
0
|
116
|
75
|
82
|
22
|
20
|
|
Period B (Week 16 to Week 52)
Received RZB as Rescue Medication
|
0
|
0
|
47
|
0
|
1
|
0
|
|
Period B (Week 16 to Week 52)
COMPLETED
|
0
|
69
|
42
|
57
|
15
|
13
|
|
Period B (Week 16 to Week 52)
NOT COMPLETED
|
0
|
49
|
36
|
26
|
7
|
7
|
Reasons for withdrawal
| Measure |
Period A: APR
Apremilast 30 mg orally twice daily (BID) up to Week 16
|
Periods A/B: RZB/RZB
Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
|
Period B: APR/APR, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders \[NR\]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB, NR
Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
|
Period B: APR/APR, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders \[R\]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB, R
Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
|
|---|---|---|---|---|---|---|
|
Period A (Baseline to Week 16)
Lost to Follow-up
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Period A (Baseline to Week 16)
Withdrawal by Subject
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Period A (Baseline to Week 16)
Other, Not Specified
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Period B (Week 16 to Week 52)
Lost to Follow-up
|
0
|
6
|
4
|
6
|
0
|
0
|
|
Period B (Week 16 to Week 52)
Withdrawal by Subject
|
0
|
5
|
13
|
2
|
3
|
0
|
|
Period B (Week 16 to Week 52)
Other, Not Specified
|
0
|
38
|
19
|
18
|
4
|
7
|
Baseline Characteristics
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Baseline characteristics by cohort
| Measure |
Period A: APR
n=234 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 13.63 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 14.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT\_A Population: all participants randomized in Period A
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Period A: APR
n=234 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
|
5.1 percentage of participants
Interval 2.3 to 8.0
|
55.9 percentage of participants
Interval 47.0 to 64.9
|
PRIMARY outcome
Timeframe: Week 16Population: ITT\_A Population: all participants randomized in Period A.
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Period A: APR
n=234 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
|
18.4 percentage of participants
Interval 13.4 to 23.3
|
75.4 percentage of participants
Interval 67.7 to 83.2
|
PRIMARY outcome
Timeframe: Week 52Population: ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Period A: APR
n=78 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=83 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
|
2.6 percentage of participants
Interval 0.0 to 6.1
|
72.3 percentage of participants
Interval 62.7 to 81.9
|
SECONDARY outcome
Timeframe: Week 16Population: ITT\_A Population: all participants randomized in Period A
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Period A: APR
n=234 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
|
18.8 percentage of participants
Interval 13.8 to 23.8
|
84.7 percentage of participants
Interval 78.3 to 91.2
|
SECONDARY outcome
Timeframe: Week 52Population: ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Period A: APR
n=78 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=83 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
|
11.5 percentage of participants
Interval 4.4 to 18.6
|
83.1 percentage of participants
Interval 75.1 to 91.2
|
SECONDARY outcome
Timeframe: Week 52Population: ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Period A: APR
n=78 Participants
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=83 Participants
Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
|
7.7 percentage of participants
Interval 1.8 to 13.6
|
77.1 percentage of participants
Interval 68.1 to 86.1
|
Adverse Events
Period A: APR
Serious events: 4 serious events
Other events: 101 other events
Deaths: 0 deaths
Period A: RZB
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Period B: RZB/RZB
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Period B: APR/APR
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Period B: APR/RZB
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Period B: APR/APR/RZB
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period A: APR
n=234 participants at risk
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 participants at risk
Risankizumab 150 mg as a single SC injection at Day 1 and Week 4
|
Period B: RZB/RZB
n=116 participants at risk
Participants who received risankizumab 150 mg as a single subcutaneous (SC) injection at Day 1 and continued on risankizumab at Weeks 16, 28, and 40
|
Period B: APR/APR
n=97 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB
n=102 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, 44.
|
Period B: APR/APR/RZB
n=48 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID and received rescue medication with risankizumab.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.43%
1/234 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.0%
1/97 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Gastrointestinal disorders
OBSTRUCTIVE PANCREATITIS
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Infections and infestations
SEPSIS
|
0.43%
1/234 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
0.43%
1/234 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.0%
1/97 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.43%
1/234 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.85%
1/118 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.7%
2/116 • Number of events 2 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/234 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 2 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
Other adverse events
| Measure |
Period A: APR
n=234 participants at risk
Apremilast 30 mg orally BID up to Week 16
|
Period A: RZB
n=118 participants at risk
Risankizumab 150 mg as a single SC injection at Day 1 and Week 4
|
Period B: RZB/RZB
n=116 participants at risk
Participants who received risankizumab 150 mg as a single subcutaneous (SC) injection at Day 1 and continued on risankizumab at Weeks 16, 28, and 40
|
Period B: APR/APR
n=97 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID up to Week 52.
|
Period B: APR/RZB
n=102 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, 44.
|
Period B: APR/APR/RZB
n=48 participants at risk
Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID and received rescue medication with risankizumab.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
20.1%
47/234 • Number of events 50 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.85%
1/118 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/116 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.0%
1/97 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Gastrointestinal disorders
NAUSEA
|
17.5%
41/234 • Number of events 45 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/118 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.7%
2/116 • Number of events 2 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
3.1%
3/97 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/102 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/48 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Infections and infestations
COVID-19
|
6.8%
16/234 • Number of events 16 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
11.0%
13/118 • Number of events 13 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
16.4%
19/116 • Number of events 20 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
14.4%
14/97 • Number of events 14 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
11.8%
12/102 • Number of events 12 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
12.5%
6/48 • Number of events 6 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.3%
10/234 • Number of events 13 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
3.4%
4/118 • Number of events 5 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
9.5%
11/116 • Number of events 14 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
8.2%
8/97 • Number of events 10 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
9.8%
10/102 • Number of events 11 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
10.4%
5/48 • Number of events 6 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.85%
2/234 • Number of events 2 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
2.5%
3/118 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
4.3%
5/116 • Number of events 5 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
3.1%
3/97 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
5.9%
6/102 • Number of events 8 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
2.1%
1/48 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Nervous system disorders
HEADACHE
|
11.5%
27/234 • Number of events 28 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
2.5%
3/118 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.86%
1/116 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
4.1%
4/97 • Number of events 4 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
4.9%
5/102 • Number of events 6 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
2.1%
1/48 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
|
Vascular disorders
HYPERTENSION
|
1.3%
3/234 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
1.7%
2/118 • Number of events 2 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
5.2%
6/116 • Number of events 6 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.00%
0/97 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
0.98%
1/102 • Number of events 1 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
6.2%
3/48 • Number of events 3 • All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).
Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER