Trial Outcomes & Findings for Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA) (NCT NCT04888585)
NCT ID: NCT04888585
Last Updated: 2024-10-08
Results Overview
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician's Global Assessment of Disease Activity (NRS) * Patient's Global Assessment of Disease Activity (NRS) * Patient's Assessment of Pain (NRS) * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
473 participants
Primary outcome timeframe
Week 12
Results posted on
2024-10-08
Participant Flow
A total of 473 participants (All Randomized Population) were enrolled in the study.
The ITT Population included all participants who were randomized and received at least 1 dose of study drug. One randomized participant (ABBV-154 150 mg EOW) was not treated and thus not included in the ITT population (N=472).
Participant milestones
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
Participants in this group received placebo SC eow for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo-Controlled (Baseline-Week 12)
STARTED
|
96
|
98
|
95
|
90
|
94
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled (Baseline-Week 12)
COMPLETED
|
92
|
93
|
86
|
85
|
89
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled (Baseline-Week 12)
NOT COMPLETED
|
4
|
5
|
9
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Extension (Wk 13-End of Study)
STARTED
|
0
|
0
|
0
|
0
|
0
|
45
|
46
|
93
|
86
|
85
|
89
|
|
Long Term Extension (Wk 13-End of Study)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Extension (Wk 13-End of Study)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
45
|
46
|
93
|
86
|
85
|
89
|
Reasons for withdrawal
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
Participants in this group received placebo SC eow for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo-Controlled (Baseline-Week 12)
Other
|
4
|
4
|
4
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled (Baseline-Week 12)
Withdrawal by Subject
|
0
|
1
|
4
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled (Baseline-Week 12)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Extension (Wk 13-End of Study)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
|
Long Term Extension (Wk 13-End of Study)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
8
|
8
|
8
|
11
|
|
Long Term Extension (Wk 13-End of Study)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
37
|
36
|
78
|
71
|
71
|
72
|
|
Long Term Extension (Wk 13-End of Study)
Other
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
4
|
5
|
5
|
3
|
|
Long Term Extension (Wk 13-End of Study)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
2
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Total
n=472 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
56.2 Years
STANDARD_DEVIATION 10.17 • n=7 Participants
|
56.8 Years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 10.72 • n=4 Participants
|
57.9 Years
STANDARD_DEVIATION 10.70 • n=21 Participants
|
57.6 Years
STANDARD_DEVIATION 10.58 • n=8 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
373 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
99 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
82 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
390 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
369 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician's Global Assessment of Disease Activity (NRS) * Patient's Global Assessment of Disease Activity (NRS) * Patient's Assessment of Pain (NRS) * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12
|
6.3 Percentage of participants
Interval 1.4 to 11.1
|
25.5 Percentage of participants
Interval 16.9 to 34.1
|
33.3 Percentage of participants
Interval 23.7 to 42.9
|
44.4 Percentage of participants
Interval 34.2 to 54.7
|
30.9 Percentage of participants
Interval 21.5 to 40.2
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=93 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=95 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=90 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=86 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
|
-1.08 units on a scale
Interval -1.35 to -0.82
|
-1.59 units on a scale
Interval -1.85 to -1.33
|
-2.09 units on a scale
Interval -2.37 to -1.82
|
-2.51 units on a scale
Interval -2.78 to -2.23
|
-1.71 units on a scale
Interval -1.96 to -1.45
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Intent-to-treat analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=92 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=91 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=88 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=86 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=93 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Change in Clinical Disease Activity Index (CDAI) at Week 12
|
-14.21 units on a scale
Interval -16.81 to -11.6
|
-18.77 units on a scale
Interval -21.41 to -16.13
|
-22.21 units on a scale
Interval -24.94 to -19.48
|
-25.62 units on a scale
Interval -28.31 to -22.93
|
-19.50 units on a scale
Interval -22.06 to -16.94
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician's Global Assessment of Disease Activity (NRS) * Patient's Global Assessment of Disease Activity (NRS) * Patient's Assessment of Pain (NRS) * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
|
28.1 percentage of participants
Interval 19.1 to 37.1
|
52.7 percentage of participants
Interval 42.7 to 62.7
|
59.3 percentage of participants
Interval 49.3 to 69.2
|
74.4 percentage of participants
Interval 65.4 to 83.5
|
54.3 percentage of participants
Interval 44.2 to 64.3
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician's Global Assessment of Disease Activity (NRS) * Patient's Global Assessment of Disease Activity (NRS) * Patient's Assessment of Pain (NRS) * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
|
3.1 percentage of participants
Interval 0.0 to 6.6
|
9.2 percentage of participants
Interval 3.5 to 14.9
|
12.8 percentage of participants
Interval 6.1 to 19.6
|
13.3 percentage of participants
Interval 6.3 to 20.4
|
4.3 percentage of participants
Interval 0.2 to 8.3
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Low disease activity (LDA) was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS) and Physician's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
|
20.8 percentage of participants
Interval 12.7 to 29.0
|
38.9 percentage of participants
Interval 29.2 to 48.6
|
48.2 percentage of participants
Interval 38.0 to 58.3
|
53.3 percentage of participants
Interval 43.0 to 63.6
|
45.7 percentage of participants
Interval 35.7 to 55.8
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Low disease activity based on CDAI is defined as a CDAI score less than or equal to 10. CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12
|
21.9 percentage of participants
Interval 13.6 to 30.1
|
36.8 percentage of participants
Interval 27.3 to 46.4
|
46.1 percentage of participants
Interval 36.0 to 56.2
|
46.7 percentage of participants
Interval 36.4 to 57.0
|
36.2 percentage of participants
Interval 26.5 to 45.9
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12
|
12.5 percentage of participants
Interval 5.9 to 19.1
|
18.4 percentage of participants
Interval 10.7 to 26.1
|
33.0 percentage of participants
Interval 23.5 to 42.6
|
37.8 percentage of participants
Interval 27.8 to 47.8
|
27.7 percentage of participants
Interval 18.6 to 36.7
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Clinical Remission was defined by CDAI as a score less than or equal to 2.8. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=94 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12
|
2.1 percentage of participants
Interval 0.0 to 4.9
|
9.2 percentage of participants
Interval 3.5 to 14.9
|
4.3 percentage of participants
Interval 0.2 to 8.3
|
4.4 percentage of participants
Interval 0.2 to 8.7
|
3.2 percentage of participants
Interval 0.0 to 6.7
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Intent-to-treat analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
The Health Assessment Questionnaire - Disability Index is a participant-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=94 Participants
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=95 Participants
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=90 Participants
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=86 Participants
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 Participants
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12
|
-0.08 units on a scale
Interval -0.19 to 0.03
|
-0.26 units on a scale
Interval -0.36 to -0.15
|
-0.33 units on a scale
Interval -0.45 to -0.22
|
-0.41 units on a scale
Interval -0.52 to -0.29
|
-0.29 units on a scale
Interval -0.39 to -0.18
|
Adverse Events
Period 1 (Placebo-Controlled Period) Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Period 2 (Extension Period) ABBV-154 40 mg EOW
Serious events: 7 serious events
Other events: 54 other events
Deaths: 1 deaths
Period 2 (Extension Period) ABBV-154 150 mg EOW
Serious events: 8 serious events
Other events: 56 other events
Deaths: 0 deaths
Period 2 (Extension Period) ABBV-154 340 mg EOW
Serious events: 10 serious events
Other events: 52 other events
Deaths: 0 deaths
Period 2 (Extension Period) ABBV-154 340 mg E4W
Serious events: 9 serious events
Other events: 47 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 participants at risk
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 participants at risk
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=95 participants at risk
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 participants at risk
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 participants at risk
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
n=45 participants at risk
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 150mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
n=46 participants at risk
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 340mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 40 mg EOW
n=91 participants at risk
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 150 mg EOW
n=86 participants at risk
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg EOW
n=84 participants at risk
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg E4W
n=89 participants at risk
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Hepatobiliary disorders
CHOLANGITIS ACUTE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
COVID-19
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
INFECTIOUS MONONUCLEOSIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
NEUROLOGICAL INFECTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
OPPORTUNISTIC INFECTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/89 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
Q FEVER
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
SEPSIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/89 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
LIMB FRACTURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
SYNOVIAL RUPTURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.3%
2/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
STROKE IN EVOLUTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/86 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/86 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
Other adverse events
| Measure |
Period 1 (Placebo-Controlled Period) Placebo
n=96 participants at risk
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
n=98 participants at risk
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
n=95 participants at risk
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
n=90 participants at risk
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
n=94 participants at risk
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
n=45 participants at risk
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 150mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
n=46 participants at risk
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 340mg SC EOW for 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 40 mg EOW
n=91 participants at risk
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 150 mg EOW
n=86 participants at risk
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg EOW
n=84 participants at risk
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
Period 2 (Extension Period) ABBV-154 340 mg E4W
n=89 participants at risk
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
INJECTION SITE ERYTHEMA
|
1.0%
1/96 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.1%
3/98 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.3%
3/90 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.4%
6/94 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
2/45 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.5%
3/46 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
7.7%
7/91 • Number of events 35 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.0%
5/84 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.6%
5/89 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.0%
2/98 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/95 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.3%
3/91 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.8%
5/86 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.4%
2/84 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/89 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Gastrointestinal disorders
NAUSEA
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/94 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.3%
2/46 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/91 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.8%
5/86 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/89 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
General disorders
INJECTION SITE BRUISING
|
2.1%
2/96 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.1%
3/98 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
10.9%
5/46 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/91 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.3%
2/86 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.4%
2/84 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.7%
6/89 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
General disorders
INJECTION SITE DISCOLOURATION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.1%
3/98 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
8.9%
4/45 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.5%
3/46 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/91 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.8%
5/86 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.4%
3/89 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
8.3%
7/84 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
General disorders
PYREXIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.6%
6/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
BRONCHITIS
|
2.1%
2/96 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.0%
2/98 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.6%
6/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.3%
2/86 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.4%
2/84 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.7%
6/89 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
COVID-19
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
13.3%
13/98 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.3%
5/95 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
7.4%
7/94 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
26.7%
12/45 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
17.4%
8/46 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
16.5%
15/91 • Number of events 17 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
17.4%
15/86 • Number of events 16 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
20.2%
17/84 • Number of events 18 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
18.0%
16/89 • Number of events 17 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
11.1%
5/45 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.5%
4/89 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.1%
2/96 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.0%
2/98 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.2%
4/95 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/94 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
8.9%
4/45 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
8.7%
4/46 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
9.9%
9/91 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
12.8%
11/86 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
7.1%
6/84 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
12.4%
11/89 • Number of events 15 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.5%
5/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.1%
3/98 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
4/90 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.3%
4/94 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
20.0%
9/45 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
10.9%
5/46 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.6%
6/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
9.3%
8/86 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
14.3%
12/84 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
7.9%
7/89 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
3/96 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.1%
5/98 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
17.8%
8/45 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
10.9%
5/46 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.3%
3/91 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
7.0%
6/86 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
9.5%
8/84 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.6%
5/89 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/95 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/91 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.8%
5/86 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Injury, poisoning and procedural complications
FALL
|
1.0%
1/96 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.0%
1/98 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.6%
6/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.3%
2/86 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.0%
2/98 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/95 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/94 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.6%
6/91 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.1%
2/96 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.1%
3/98 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/95 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.3%
3/91 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
9.3%
8/86 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/89 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
7.3%
7/96 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.1%
5/98 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.1%
2/95 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.1%
2/94 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
11.1%
5/45 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
8.7%
4/46 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
11.0%
10/91 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
12.8%
11/86 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.0%
5/84 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
9.0%
8/89 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Nervous system disorders
HEADACHE
|
3.1%
3/96 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.1%
4/98 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/95 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.1%
2/94 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.3%
3/91 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.8%
5/86 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/89 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.0%
2/98 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.2%
3/95 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.1%
2/94 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
6.5%
3/46 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
4/91 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.7%
4/86 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/89 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/96 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
0.00%
0/98 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.1%
2/95 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
1.1%
1/94 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.4%
4/91 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
3.5%
3/86 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
4.8%
4/84 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
5.6%
5/89 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
All Randomized Population (N=473)
|
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