MedTrace Logo

Trial Outcomes & Findings for A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib (NCT NCT03823378)

NCT ID: NCT03823378

Last Updated: 2021-09-16

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks

Results posted on

2021-09-16

Participant Flow

All randomized participants

Participant milestones

Participant milestones
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Overall Study
STARTED
28
16
12
12
20
9
Overall Study
COMPLETED
7
0
2
2
2
1
Overall Study
NOT COMPLETED
21
16
10
10
18
8

Reasons for withdrawal

Reasons for withdrawal
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Overall Study
Adverse Event
2
2
0
0
0
0
Overall Study
Lost to Follow-up
0
1
0
0
1
0
Overall Study
Withdrawal by Subject
0
1
4
2
0
1
Overall Study
Other, not specified
19
12
6
8
17
7

Baseline Characteristics

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=12 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Total
n=97 Participants
Total of all reporting groups
Age, Continuous
57.5 years
STANDARD_DEVIATION 12.64 • n=99 Participants
58.6 years
STANDARD_DEVIATION 8.75 • n=107 Participants
58.5 years
STANDARD_DEVIATION 12.07 • n=206 Participants
54.5 years
STANDARD_DEVIATION 12.21 • n=7 Participants
61.7 years
STANDARD_DEVIATION 8.99 • n=31 Participants
59.4 years
STANDARD_DEVIATION 9.48 • n=30 Participants
58.5 years
STANDARD_DEVIATION 10.89 • n=3 Participants
Sex: Female, Male
Female
18 Participants
n=99 Participants
14 Participants
n=107 Participants
12 Participants
n=206 Participants
8 Participants
n=7 Participants
18 Participants
n=31 Participants
7 Participants
n=30 Participants
77 Participants
n=3 Participants
Sex: Female, Male
Male
10 Participants
n=99 Participants
2 Participants
n=107 Participants
0 Participants
n=206 Participants
4 Participants
n=7 Participants
2 Participants
n=31 Participants
2 Participants
n=30 Participants
20 Participants
n=3 Participants
Race/Ethnicity, Customized
White
27 Participants
n=99 Participants
15 Participants
n=107 Participants
12 Participants
n=206 Participants
12 Participants
n=7 Participants
20 Participants
n=31 Participants
9 Participants
n=30 Participants
95 Participants
n=3 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Duration of Rheumatoid Arthritis Diagnosis
10.024 years
STANDARD_DEVIATION 5.6087 • n=99 Participants
14.212 years
STANDARD_DEVIATION 9.0327 • n=107 Participants
5.435 years
STANDARD_DEVIATION 3.2458 • n=206 Participants
9.466 years
STANDARD_DEVIATION 6.6508 • n=7 Participants
13.571 years
STANDARD_DEVIATION 7.8086 • n=31 Participants
9.684 years
STANDARD_DEVIATION 5.6087 • n=30 Participants
10.778 years
STANDARD_DEVIATION 7.0861 • n=3 Participants

PRIMARY outcome

Timeframe: On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks

Population: Safety Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=12 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Number of Participants With Adverse Events (AEs)
11 Participants
10 Participants
3 Participants
5 Participants
7 Participants
3 Participants

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The DAS28-CRP 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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 18
-3.27 units on a scale
Interval -3.79 to -2.75
-1.98 units on a scale
Interval -2.83 to -1.12
-1.93 units on a scale
Interval -3.01 to -0.85
-2.55 units on a scale
Interval -3.5 to -1.6
-3.88 units on a scale
Interval -4.63 to -3.14
-2.87 units on a scale
Interval -4.05 to -1.68
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 24
-3.43 units on a scale
Interval -3.9 to -2.95
-2.62 units on a scale
Interval -3.56 to -1.68
-2.02 units on a scale
Interval -3.18 to -0.86
-3.20 units on a scale
Interval -4.1 to -2.3
-4.02 units on a scale
Interval -4.62 to -3.43
-3.61 units on a scale
Interval -4.94 to -2.28
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 30
-3.17 units on a scale
Interval -3.86 to -2.47
-2.37 units on a scale
Interval -3.71 to -1.03
-1.45 units on a scale
Interval -2.3 to -0.6
-3.30 units on a scale
Interval -4.43 to -2.17
-3.84 units on a scale
Interval -4.56 to -3.12
-4.08 units on a scale
Interval -4.73 to -3.44
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 36
-3.45 units on a scale
Interval -4.14 to -2.77
-3.12 units on a scale
Interval -3.99 to -2.25
-1.63 units on a scale
Interval -2.37 to -0.89
-3.00 units on a scale
Interval -4.17 to -1.83
-4.15 units on a scale
Interval -5.02 to -3.29
-3.77 units on a scale
Interval -4.79 to -2.74
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 48
-3.55 units on a scale
Interval -4.32 to -2.78
-2.77 units on a scale
Interval -4.92 to -0.62
-1.68 units on a scale
Interval -3.1 to -0.27
-3.16 units on a scale
Interval -4.49 to -1.84
-4.38 units on a scale
Interval -5.67 to -3.09
-3.86 units on a scale
Interval -4.88 to -2.85
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Week 60
-4.06 units on a scale
Interval -4.88 to -3.25
-3.21 units on a scale
Interval -22.18 to 15.75
-2.55 units on a scale
Interval -6.9 to 1.79
-3.41 units on a scale
Interval -4.92 to -1.89
-4.12 units on a scale
Interval -5.43 to -2.81
-3.69 units on a scale
Interval -5.19 to -2.19

SECONDARY outcome

Timeframe: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The DAS28-CRP 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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=27 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=9 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 18
78.3 percentage of participants
Interval 58.1 to 90.34
26.7 percentage of participants
Interval 10.9 to 51.95
44.4 percentage of participants
Interval 18.88 to 73.33
20.0 percentage of participants
Interval 5.67 to 50.98
77.8 percentage of participants
Interval 54.79 to 91.0
62.5 percentage of participants
Interval 30.57 to 86.32
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 24
77.8 percentage of participants
Interval 59.24 to 89.39
53.8 percentage of participants
Interval 29.14 to 76.79
44.4 percentage of participants
Interval 18.88 to 73.33
50.0 percentage of participants
Interval 23.66 to 76.34
88.2 percentage of participants
Interval 65.66 to 96.71
85.7 percentage of participants
Interval 48.69 to 97.43
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 30
78.3 percentage of participants
Interval 58.1 to 90.34
76.9 percentage of participants
Interval 49.74 to 91.82
28.6 percentage of participants
Interval 8.22 to 64.11
60.0 percentage of participants
Interval 31.27 to 83.18
87.5 percentage of participants
Interval 63.98 to 96.5
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 36
87.5 percentage of participants
Interval 69.0 to 95.66
87.5 percentage of participants
Interval 52.91 to 97.76
25.0 percentage of participants
Interval 4.56 to 69.94
40.0 percentage of participants
Interval 16.82 to 68.73
91.7 percentage of participants
Interval 64.61 to 98.51
100 percentage of participants
Interval 60.97 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 48
77.8 percentage of participants
Interval 54.79 to 91.0
66.7 percentage of participants
Interval 30.0 to 90.32
50.0 percentage of participants
Interval 15.0 to 85.0
37.5 percentage of participants
Interval 13.68 to 69.43
87.5 percentage of participants
Interval 52.91 to 97.76
100 percentage of participants
Interval 60.97 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 60
100 percentage of participants
Interval 70.09 to 100.0
50.0 percentage of participants
Interval 9.45 to 90.55
100 percentage of participants
Interval 34.24 to 100.0
60.0 percentage of participants
Interval 23.07 to 88.24
100 percentage of participants
Interval 56.55 to 100.0
75.0 percentage of participants
Interval 30.06 to 95.44

SECONDARY outcome

Timeframe: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The DAS28-CRP 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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=27 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=9 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 18
56.5 percentage of participants
Interval 36.81 to 74.37
20.0 percentage of participants
Interval 7.05 to 45.19
11.1 percentage of participants
Interval 1.99 to 43.5
20.0 percentage of participants
Interval 5.67 to 50.98
77.8 percentage of participants
Interval 54.79 to 91.0
50.0 percentage of participants
Interval 21.52 to 78.48
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 24
70.4 percentage of participants
Interval 51.52 to 84.15
53.8 percentage of participants
Interval 29.14 to 76.79
33.3 percentage of participants
Interval 12.06 to 64.58
30.0 percentage of participants
Interval 10.78 to 60.32
70.6 percentage of participants
Interval 46.87 to 86.72
71.4 percentage of participants
Interval 35.89 to 91.78
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 30
65.2 percentage of participants
Interval 44.89 to 81.19
46.2 percentage of participants
Interval 23.21 to 70.86
0 percentage of participants
Interval 0.0 to 35.43
40.0 percentage of participants
Interval 16.82 to 68.73
87.5 percentage of participants
Interval 63.98 to 96.5
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 36
66.7 percentage of participants
Interval 46.71 to 82.03
62.5 percentage of participants
Interval 30.57 to 86.32
0 percentage of participants
Interval 0.0 to 48.99
20.0 percentage of participants
Interval 5.67 to 50.98
75.0 percentage of participants
Interval 46.77 to 91.11
66.7 percentage of participants
Interval 30.0 to 90.32
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 48
72.2 percentage of participants
Interval 49.13 to 87.5
66.7 percentage of participants
Interval 30.0 to 90.32
0 percentage of participants
Interval 0.0 to 48.99
25.0 percentage of participants
Interval 7.15 to 59.07
62.5 percentage of participants
Interval 30.57 to 86.32
83.3 percentage of participants
Interval 43.65 to 96.99
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Week 60
77.8 percentage of participants
Interval 45.26 to 93.68
50.0 percentage of participants
Interval 9.45 to 90.55
50.0 percentage of participants
Interval 9.45 to 90.55
0 percentage of participants
Interval 0.0 to 43.45
60.0 percentage of participants
Interval 23.07 to 88.24
75.0 percentage of participants
Interval 30.06 to 95.44

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The 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 global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=9 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 18
-33.68 units on a scale
Interval -40.72 to -26.64
-23.77 units on a scale
Interval -32.65 to -14.9
-19.16 units on a scale
Interval -28.05 to -10.26
-27.00 units on a scale
Interval -42.89 to -11.11
-36.01 units on a scale
Interval -44.11 to -27.91
-28.65 units on a scale
Interval -37.0 to -20.3
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 24
-33.47 units on a scale
Interval -39.66 to -27.27
-27.20 units on a scale
Interval -34.18 to -20.22
-19.84 units on a scale
Interval -30.65 to -9.03
-35.59 units on a scale
Interval -45.25 to -25.93
-38.27 units on a scale
Interval -45.66 to -30.88
-32.93 units on a scale
Interval -41.7 to -24.15
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 30
-32.07 units on a scale
Interval -40.11 to -24.03
-22.40 units on a scale
Interval -34.25 to -10.55
-16.72 units on a scale
Interval -22.28 to -11.16
-35.92 units on a scale
Interval -46.64 to -25.2
-36.86 units on a scale
Interval -46.2 to -27.52
-34.00 units on a scale
Interval -42.21 to -25.79
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 36
-35.28 units on a scale
Interval -43.23 to -27.33
-28.86 units on a scale
Interval -36.56 to -21.16
-19.17 units on a scale
Interval -32.1 to -6.23
-33.99 units on a scale
Interval -47.1 to -20.88
-42.20 units on a scale
Interval -52.14 to -32.26
-32.92 units on a scale
Interval -41.43 to -24.4
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 48
-36.26 units on a scale
Interval -45.44 to -27.08
-22.58 units on a scale
Interval -41.15 to -4.02
-18.87 units on a scale
Interval -36.4 to -1.33
-34.77 units on a scale
Interval -49.11 to -20.44
-45.69 units on a scale
Interval -57.45 to -33.93
-35.72 units on a scale
Interval -45.75 to -25.69
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Week 60
-37.99 units on a scale
Interval -49.56 to -26.41
-29.70 units on a scale
Interval -216.48 to 157.08
-24.95 units on a scale
Interval -78.95 to 29.05
-37.20 units on a scale
Interval -56.11 to -18.29
-43.98 units on a scale
Interval -58.77 to -29.19
-34.38 units on a scale
Interval -46.14 to -22.61

SECONDARY outcome

Timeframe: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The 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 global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=27 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=9 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 48
77.8 percentage of participants
Interval 54.79 to 91.0
66.7 percentage of participants
Interval 30.0 to 90.32
75.0 percentage of participants
Interval 30.06 to 95.44
62.5 percentage of participants
Interval 30.57 to 86.32
87.5 percentage of participants
Interval 52.91 to 97.76
100 percentage of participants
Interval 56.55 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 60
100 percentage of participants
Interval 70.09 to 100.0
50.0 percentage of participants
Interval 9.45 to 90.55
100 percentage of participants
Interval 34.24 to 100.0
80.0 percentage of participants
Interval 37.55 to 96.38
80.0 percentage of participants
Interval 37.55 to 96.38
75.0 percentage of participants
Interval 30.06 to 95.44
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 18
82.6 percentage of participants
Interval 62.86 to 93.02
40.0 percentage of participants
Interval 19.82 to 64.25
44.4 percentage of participants
Interval 18.88 to 73.33
50.0 percentage of participants
Interval 21.52 to 78.48
77.8 percentage of participants
Interval 54.79 to 91.0
62.5 percentage of participants
Interval 30.57 to 86.32
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 24
88.9 percentage of participants
Interval 71.94 to 96.15
69.2 percentage of participants
Interval 42.37 to 87.32
55.6 percentage of participants
Interval 26.67 to 81.12
80.0 percentage of participants
Interval 49.02 to 94.33
88.2 percentage of participants
Interval 65.66 to 96.71
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 30
78.3 percentage of participants
Interval 58.1 to 90.34
76.9 percentage of participants
Interval 49.74 to 91.82
42.9 percentage of participants
Interval 15.82 to 74.95
80.0 percentage of participants
Interval 49.02 to 94.33
81.3 percentage of participants
Interval 56.99 to 93.41
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 36
86.4 percentage of participants
Interval 66.67 to 95.25
87.5 percentage of participants
Interval 52.91 to 97.76
75.0 percentage of participants
Interval 30.06 to 95.44
70.0 percentage of participants
Interval 39.68 to 89.22
83.3 percentage of participants
Interval 55.2 to 95.3
100 percentage of participants
Interval 60.97 to 100.0

SECONDARY outcome

Timeframe: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The 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 global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a total CDAI score of less than or equal to 2.8.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=27 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=9 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 18
17.4 percentage of participants
Interval 6.98 to 37.14
13.3 percentage of participants
Interval 3.74 to 37.88
11.1 percentage of participants
Interval 1.99 to 43.5
12.5 percentage of participants
Interval 2.24 to 47.09
55.6 percentage of participants
Interval 33.72 to 75.44
25.0 percentage of participants
Interval 7.15 to 59.07
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 24
29.6 percentage of participants
Interval 15.85 to 48.48
23.1 percentage of participants
Interval 8.18 to 50.26
11.1 percentage of participants
Interval 1.99 to 43.5
10.0 percentage of participants
Interval 1.79 to 40.42
58.8 percentage of participants
Interval 36.01 to 78.39
50.0 percentage of participants
Interval 21.52 to 78.48
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 30
26.1 percentage of participants
Interval 12.55 to 46.47
30.8 percentage of participants
Interval 12.68 to 57.63
14.3 percentage of participants
Interval 2.57 to 51.31
30.0 percentage of participants
Interval 10.78 to 60.32
43.8 percentage of participants
Interval 23.1 to 66.82
87.5 percentage of participants
Interval 52.91 to 97.76
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 36
36.4 percentage of participants
Interval 19.73 to 57.05
25.0 percentage of participants
Interval 7.15 to 59.07
25.0 percentage of participants
Interval 4.56 to 69.94
10.0 percentage of participants
Interval 1.79 to 40.42
41.7 percentage of participants
Interval 19.33 to 68.05
50.0 percentage of participants
Interval 18.76 to 81.24
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 48
44.4 percentage of participants
Interval 24.56 to 66.28
33.3 percentage of participants
Interval 9.68 to 70.0
0 percentage of participants
Interval 0.0 to 48.99
12.5 percentage of participants
Interval 2.24 to 47.09
50.0 percentage of participants
Interval 21.52 to 78.48
100 percentage of participants
Interval 56.55 to 100.0
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 60
33.3 percentage of participants
Interval 12.06 to 64.58
50.0 percentage of participants
Interval 9.45 to 90.55
50.0 percentage of participants
Interval 9.45 to 90.55
20.0 percentage of participants
Interval 3.62 to 62.45
60.0 percentage of participants
Interval 23.07 to 88.24
50.0 percentage of participants
Interval 15.0 to 85.0

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria: 1. ≥ 20% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 20% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 20% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 18
90.9 percentage of participants
Interval 72.19 to 97.47
80.0 percentage of participants
Interval 54.81 to 92.95
57.1 percentage of participants
Interval 25.05 to 84.18
66.7 percentage of participants
Interval 35.42 to 87.94
88.2 percentage of participants
Interval 65.66 to 96.71
75.0 percentage of participants
Interval 40.93 to 92.85
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 24
96.2 percentage of participants
Interval 81.11 to 99.32
92.9 percentage of participants
Interval 68.53 to 98.73
85.7 percentage of participants
Interval 48.69 to 97.43
77.8 percentage of participants
Interval 45.26 to 93.68
93.8 percentage of participants
Interval 71.67 to 98.89
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 30
86.4 percentage of participants
Interval 66.67 to 95.25
69.2 percentage of participants
Interval 42.37 to 87.32
50.0 percentage of participants
Interval 18.76 to 81.24
80.0 percentage of participants
Interval 49.02 to 94.33
87.5 percentage of participants
Interval 63.98 to 96.5
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 36
87.0 percentage of participants
Interval 67.87 to 95.46
87.5 percentage of participants
Interval 52.91 to 97.76
66.7 percentage of participants
Interval 20.77 to 93.85
88.9 percentage of participants
Interval 56.5 to 98.01
91.7 percentage of participants
Interval 64.61 to 98.51
83.3 percentage of participants
Interval 43.65 to 96.99
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 48
94.1 percentage of participants
Interval 73.02 to 98.95
83.3 percentage of participants
Interval 43.65 to 96.99
66.7 percentage of participants
Interval 20.77 to 93.85
85.7 percentage of participants
Interval 48.69 to 97.43
87.5 percentage of participants
Interval 52.91 to 97.76
100 percentage of participants
Interval 60.97 to 100.0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 60
88.9 percentage of participants
Interval 56.5 to 98.01
100 percentage of participants
Interval 34.24 to 100.0
100 percentage of participants
Interval 34.24 to 100.0
75.0 percentage of participants
Interval 30.06 to 95.44
100 percentage of participants
Interval 56.55 to 100.0
100 percentage of participants
Interval 51.01 to 100.0

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria: 1. ≥ 50% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 50% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 50% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=10 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 18
68.2 percentage of participants
Interval 47.32 to 83.64
46.7 percentage of participants
Interval 24.81 to 69.88
40.0 percentage of participants
Interval 16.82 to 68.73
40.0 percentage of participants
Interval 16.82 to 68.73
70.6 percentage of participants
Interval 46.87 to 86.72
62.5 percentage of participants
Interval 30.57 to 86.32
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 36
82.6 percentage of participants
Interval 62.86 to 93.02
62.5 percentage of participants
Interval 30.57 to 86.32
33.3 percentage of participants
Interval 6.15 to 79.23
66.7 percentage of participants
Interval 35.42 to 87.94
75.0 percentage of participants
Interval 46.77 to 91.11
66.7 percentage of participants
Interval 30.0 to 90.32
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 48
82.4 percentage of participants
Interval 58.97 to 93.81
66.7 percentage of participants
Interval 30.0 to 90.32
66.7 percentage of participants
Interval 20.77 to 93.85
71.4 percentage of participants
Interval 35.89 to 91.78
87.5 percentage of participants
Interval 52.91 to 97.76
83.3 percentage of participants
Interval 43.65 to 96.99
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 60
88.9 percentage of participants
Interval 56.5 to 98.01
50.0 percentage of participants
Interval 9.45 to 90.55
100 percentage of participants
Interval 34.24 to 100.0
75.0 percentage of participants
Interval 30.06 to 95.44
100 percentage of participants
Interval 56.55 to 100.0
100 percentage of participants
Interval 51.01 to 100.0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 24
76.9 percentage of participants
Interval 57.95 to 88.97
64.3 percentage of participants
Interval 38.76 to 83.66
42.9 percentage of participants
Interval 15.82 to 74.95
66.7 percentage of participants
Interval 35.42 to 87.94
87.5 percentage of participants
Interval 63.98 to 96.5
100 percentage of participants
Interval 67.56 to 100.0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 30
63.6 percentage of participants
Interval 42.95 to 80.27
61.5 percentage of participants
Interval 35.52 to 82.29
16.7 percentage of participants
Interval 3.01 to 56.35
60.0 percentage of participants
Interval 31.27 to 83.18
87.5 percentage of participants
Interval 63.98 to 96.5
100 percentage of participants
Interval 67.56 to 100.0

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria: 1. ≥ 70% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 70% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 70% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=10 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 36
78.3 percentage of participants
Interval 58.1 to 90.34
50.0 percentage of participants
Interval 21.52 to 78.48
25.0 percentage of participants
Interval 4.56 to 69.94
44.4 percentage of participants
Interval 18.88 to 73.33
75.0 percentage of participants
Interval 46.77 to 91.11
66.7 percentage of participants
Interval 30.0 to 90.32
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 48
58.8 percentage of participants
Interval 36.01 to 78.39
50.0 percentage of participants
Interval 18.76 to 81.24
25.0 percentage of participants
Interval 4.56 to 69.94
42.9 percentage of participants
Interval 15.82 to 74.95
75.0 percentage of participants
Interval 40.93 to 92.85
83.3 percentage of participants
Interval 43.65 to 96.99
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 18
47.8 percentage of participants
Interval 29.24 to 67.04
33.3 percentage of participants
Interval 15.18 to 58.29
20.0 percentage of participants
Interval 5.67 to 50.98
25.0 percentage of participants
Interval 8.89 to 53.23
55.6 percentage of participants
Interval 33.72 to 75.44
37.5 percentage of participants
Interval 13.68 to 69.43
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 24
57.7 percentage of participants
Interval 38.95 to 74.46
42.9 percentage of participants
Interval 21.38 to 67.41
12.5 percentage of participants
Interval 2.24 to 47.09
55.6 percentage of participants
Interval 26.67 to 81.12
62.5 percentage of participants
Interval 38.64 to 81.52
87.5 percentage of participants
Interval 52.91 to 97.76
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 30
63.6 percentage of participants
Interval 42.95 to 80.27
46.2 percentage of participants
Interval 23.21 to 70.86
14.3 percentage of participants
Interval 2.57 to 51.31
60.0 percentage of participants
Interval 31.27 to 83.18
68.8 percentage of participants
Interval 44.4 to 85.84
87.5 percentage of participants
Interval 52.91 to 97.76
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 60
88.9 percentage of participants
Interval 56.5 to 98.01
50.0 percentage of participants
Interval 9.45 to 90.55
50.0 percentage of participants
Interval 9.45 to 90.55
25.0 percentage of participants
Interval 4.56 to 69.94
60.0 percentage of participants
Interval 23.07 to 88.24
75.0 percentage of participants
Interval 30.06 to 95.44

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=11 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 18
-11.50 swollen joint counts
Interval -13.66 to -9.34
-9.88 swollen joint counts
Interval -14.37 to -5.38
-8.00 swollen joint counts
Interval -11.28 to -4.72
-13.42 swollen joint counts
Interval -18.4 to -8.43
-12.80 swollen joint counts
Interval -16.11 to -9.49
-9.78 swollen joint counts
Interval -13.06 to -6.5
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 24
-11.67 swollen joint counts
Interval -13.85 to -9.49
-10.54 swollen joint counts
Interval -14.25 to -6.82
-7.67 swollen joint counts
Interval -10.13 to -5.21
-15.60 swollen joint counts
Interval -21.14 to -10.06
-13.24 swollen joint counts
Interval -16.48 to -9.99
-10.38 swollen joint counts
Interval -14.22 to -6.53
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 30
-11.87 swollen joint counts
Interval -14.53 to -9.21
-7.69 swollen joint counts
Interval -11.64 to -3.74
-5.86 swollen joint counts
Interval -8.27 to -3.44
-15.50 swollen joint counts
Interval -21.05 to -9.95
-13.44 swollen joint counts
Interval -17.11 to -9.77
-10.75 swollen joint counts
Interval -14.61 to -6.89
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 36
-12.38 swollen joint counts
Interval -14.84 to -9.91
-10.13 swollen joint counts
Interval -13.42 to -6.83
-7.75 swollen joint counts
Interval -11.73 to -3.77
-14.60 swollen joint counts
Interval -21.38 to -7.82
-14.25 swollen joint counts
Interval -18.71 to -9.79
-10.50 swollen joint counts
Interval -14.79 to -6.21
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 48
-13.67 swollen joint counts
Interval -16.57 to -10.77
-8.00 swollen joint counts
Interval -16.13 to 0.13
-8.00 swollen joint counts
Interval -11.9 to -4.1
-15.88 swollen joint counts
Interval -21.34 to -10.41
-15.75 swollen joint counts
Interval -21.84 to -9.66
-10.67 swollen joint counts
Interval -15.34 to -5.99
Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
Week 60
-14.44 swollen joint counts
Interval -17.73 to -11.16
-12.50 swollen joint counts
Interval -18.85 to -6.15
-7.50 swollen joint counts
Interval -39.27 to 24.27
-15.40 swollen joint counts
Interval -23.66 to -7.14
-13.00 swollen joint counts
Interval -20.8 to -5.2
-11.25 swollen joint counts
Interval -16.0 to -6.5

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=11 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 18
-17.29 tender joint counts
Interval -20.95 to -13.62
-12.69 tender joint counts
Interval -18.77 to -6.61
-9.82 tender joint counts
Interval -13.63 to -6.01
-14.17 tender joint counts
Interval -21.7 to -6.63
-19.75 tender joint counts
Interval -25.63 to -13.87
-10.67 tender joint counts
Interval -16.21 to -5.12
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 24
-17.93 tender joint counts
Interval -21.84 to -14.02
-15.77 tender joint counts
Interval -19.37 to -12.17
-8.11 tender joint counts
Interval -10.95 to -5.28
-20.20 tender joint counts
Interval -26.97 to -13.43
-20.76 tender joint counts
Interval -27.39 to -14.14
-14.25 tender joint counts
Interval -18.44 to -10.06
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 30
-16.30 tender joint counts
Interval -20.32 to -12.29
-9.54 tender joint counts
Interval -18.16 to -0.92
-4.57 tender joint counts
Interval -7.29 to -1.86
-19.80 tender joint counts
Interval -27.25 to -12.35
-20.50 tender joint counts
Interval -28.45 to -12.55
-14.88 tender joint counts
Interval -18.6 to -11.15
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 36
-16.42 tender joint counts
Interval -20.15 to -12.68
-15.25 tender joint counts
Interval -19.85 to -10.65
-8.00 tender joint counts
Interval -15.46 to -0.54
-18.40 tender joint counts
Interval -26.99 to -9.81
-24.92 tender joint counts
Interval -33.96 to -15.88
-14.83 tender joint counts
Interval -19.21 to -10.46
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 48
-17.33 tender joint counts
Interval -21.05 to -13.61
-12.33 tender joint counts
Interval -23.09 to -1.58
-5.50 tender joint counts
Interval -14.64 to 3.64
-18.88 tender joint counts
Interval -28.63 to -9.12
-28.88 tender joint counts
Interval -41.8 to -15.95
-15.00 tender joint counts
Interval -20.1 to -9.9
Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
Week 60
-19.78 tender joint counts
Interval -25.14 to -14.41
-19.00 tender joint counts
Interval -82.53 to 44.53
-11.50 tender joint counts
Interval -81.38 to 58.38
-20.20 tender joint counts
Interval -35.42 to -4.98
-26.20 tender joint counts
Interval -36.9 to -15.5
-15.50 tender joint counts
Interval -21.52 to -9.48

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 18
-49.68 units on a scale
Interval -62.42 to -36.94
-34.67 units on a scale
Interval -51.73 to -17.61
-25.57 units on a scale
Interval -56.51 to 5.37
-32.50 units on a scale
Interval -53.25 to -11.75
-56.17 units on a scale
Interval -72.4 to -39.93
-47.88 units on a scale
Interval -76.92 to -18.83
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 24
-45.46 units on a scale
Interval -58.31 to -32.61
-48.36 units on a scale
Interval -60.6 to -36.11
-29.43 units on a scale
Interval -50.47 to -8.39
-42.00 units on a scale
Interval -61.74 to -22.26
-57.76 units on a scale
Interval -73.67 to -41.86
-59.38 units on a scale
Interval -80.35 to -38.4
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 30
-48.18 units on a scale
Interval -61.9 to -34.46
-40.62 units on a scale
Interval -63.4 to -17.83
-20.00 units on a scale
Interval -48.48 to 8.48
-45.90 units on a scale
Interval -70.64 to -21.16
-53.63 units on a scale
Interval -71.19 to -36.06
-60.25 units on a scale
Interval -80.74 to -39.76
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 36
-49.22 units on a scale
Interval -61.84 to -36.59
-47.13 units on a scale
Interval -72.05 to -22.2
-25.67 units on a scale
Interval -120.27 to 68.94
-46.70 units on a scale
Interval -63.4 to -30.0
-58.83 units on a scale
Interval -80.69 to -36.98
-54.83 units on a scale
Interval -90.68 to -18.98
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 48
-60.06 units on a scale
Interval -72.78 to -47.34
-49.00 units on a scale
Interval -72.85 to -25.15
-35.00 units on a scale
Interval -69.15 to -0.85
-56.13 units on a scale
Interval -82.8 to -29.45
-58.75 units on a scale
Interval -82.8 to -34.7
-61.50 units on a scale
Interval -94.46 to -28.54
Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
Week 60
-54.67 units on a scale
Interval -77.99 to -31.34
-52.00 units on a scale
Interval -522.13 to 418.13
-45.50 units on a scale
Interval -140.8 to 49.8
-58.80 units on a scale
Interval -73.74 to -43.86
-61.00 units on a scale
Interval -88.13 to -33.87
-55.00 units on a scale
Interval -100.36 to -9.64

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=26 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=18 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 18
-45.18 units on a scale
Interval -58.36 to -32.0
-34.07 units on a scale
Interval -50.11 to -18.03
-28.57 units on a scale
Interval -61.69 to 4.55
-35.70 units on a scale
Interval -56.96 to -14.44
-56.56 units on a scale
Interval -72.18 to -40.93
-40.13 units on a scale
Interval -67.21 to -13.04
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 24
-48.62 units on a scale
Interval -59.37 to -37.87
-45.93 units on a scale
Interval -60.14 to -31.72
-33.29 units on a scale
Interval -59.62 to -6.95
-45.20 units on a scale
Interval -61.3 to -29.1
-62.47 units on a scale
Interval -76.09 to -48.85
-58.13 units on a scale
Interval -74.96 to -41.29
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 30
-46.18 units on a scale
Interval -60.77 to -31.6
-39.69 units on a scale
Interval -61.63 to -17.76
-21.40 units on a scale
Interval -57.54 to 14.74
-45.20 units on a scale
Interval -67.27 to -23.13
-56.31 units on a scale
Interval -71.7 to -40.92
-57.75 units on a scale
Interval -75.8 to -39.7
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 36
-51.70 units on a scale
Interval -64.0 to -39.39
-48.63 units on a scale
Interval -73.95 to -23.3
-31.67 units on a scale
Interval -141.65 to 78.32
-46.20 units on a scale
Interval -64.52 to -27.88
-61.00 units on a scale
Interval -81.17 to -40.83
-53.33 units on a scale
Interval -84.24 to -22.42
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 48
-54.24 units on a scale
Interval -69.66 to -38.81
-44.00 units on a scale
Interval -71.07 to -16.93
-38.67 units on a scale
Interval -88.62 to 11.28
-53.13 units on a scale
Interval -76.82 to -29.43
-60.75 units on a scale
Interval -84.13 to -37.37
-56.67 units on a scale
Interval -84.14 to -29.19
Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
Week 60
-56.67 units on a scale
Interval -83.18 to -30.16
-56.00 units on a scale
Interval -462.6 to 350.6
-54.50 units on a scale
Interval -226.03 to 117.03
-54.60 units on a scale
Interval -70.61 to -38.59
-59.80 units on a scale
Interval -96.5 to -23.1
-57.00 units on a scale
Interval -87.75 to -26.25

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=27 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=9 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 48
-56.39 units on a scale
Interval -71.53 to -41.24
-36.83 units on a scale
Interval -75.18 to 1.52
-56.67 units on a scale
Interval -93.29 to -20.04
-57.14 units on a scale
Interval -80.22 to -34.07
-66.13 units on a scale
Interval -82.33 to -49.92
-66.40 units on a scale
Interval -89.67 to -43.13
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 18
-57.22 units on a scale
Interval -65.56 to -48.87
-41.00 units on a scale
Interval -53.42 to -28.58
-33.00 units on a scale
Interval -61.23 to -4.77
-35.00 units on a scale
Interval -59.98 to -10.02
-59.06 units on a scale
Interval -69.39 to -48.72
-55.13 units on a scale
Interval -82.03 to -28.22
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 24
-57.93 units on a scale
Interval -65.61 to -50.25
-48.36 units on a scale
Interval -60.05 to -36.66
-39.43 units on a scale
Interval -70.88 to -7.98
-50.89 units on a scale
Interval -68.36 to -33.42
-61.19 units on a scale
Interval -71.9 to -50.47
-62.38 units on a scale
Interval -77.73 to -47.02
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 30
-55.04 units on a scale
Interval -64.27 to -45.82
-41.23 units on a scale
Interval -57.85 to -24.61
-41.80 units on a scale
Interval -60.33 to -23.27
-54.78 units on a scale
Interval -71.11 to -38.45
-56.20 units on a scale
Interval -73.22 to -39.18
-63.50 units on a scale
Interval -79.15 to -47.85
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 36
-57.55 units on a scale
Interval -66.96 to -48.13
-53.75 units on a scale
Interval -70.49 to -37.01
-60.00 units on a scale
Interval -112.58 to -7.42
-54.78 units on a scale
Interval -73.97 to -35.58
-68.45 units on a scale
Interval -81.66 to -55.25
-65.83 units on a scale
Interval -89.6 to -42.06
Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
Week 60
-64.33 units on a scale
Interval -79.18 to -49.48
-56.00 units on a scale
Interval -437.19 to 325.19
-65.00 units on a scale
Interval -141.24 to 11.24
-61.50 units on a scale
Interval -88.83 to -34.17
-60.00 units on a scale
Interval -88.34 to -31.66
-56.75 units on a scale
Interval -87.94 to -25.56

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

The Health Assessment Questionnaire - Disability Index is a patient-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

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=25 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 24
-0.59 units on a scale
Interval -0.81 to -0.36
-0.46 units on a scale
Interval -0.8 to -0.12
-0.57 units on a scale
Interval -1.24 to 0.09
-0.54 units on a scale
Interval -0.98 to -0.09
-0.59 units on a scale
Interval -0.94 to -0.25
-0.78 units on a scale
Interval -1.29 to -0.27
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 18
-0.57 units on a scale
Interval -0.84 to -0.29
-0.49 units on a scale
Interval -0.84 to -0.14
-0.61 units on a scale
Interval -1.27 to 0.06
-0.61 units on a scale
Interval -1.04 to -0.19
-0.85 units on a scale
Interval -1.21 to -0.5
-0.47 units on a scale
Interval -0.77 to -0.17
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 30
-0.64 units on a scale
Interval -0.91 to -0.36
-0.45 units on a scale
Interval -0.93 to 0.03
-0.15 units on a scale
Interval -0.45 to 0.15
-0.51 units on a scale
Interval -0.94 to -0.09
-0.73 units on a scale
Interval -1.1 to -0.35
-0.75 units on a scale
Interval -1.17 to -0.33
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 36
-0.67 units on a scale
Interval -0.95 to -0.38
-0.70 units on a scale
Interval -1.45 to 0.05
-0.33 units on a scale
Interval -0.81 to 0.14
-0.30 units on a scale
Interval -0.7 to 0.1
-0.51 units on a scale
Interval -0.94 to -0.09
-0.56 units on a scale
Interval -1.05 to -0.07
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 48
-0.70 units on a scale
Interval -1.06 to -0.34
-0.63 units on a scale
Interval -1.76 to 0.51
-0.29 units on a scale
Interval -0.65 to 0.07
-0.42 units on a scale
Interval -0.9 to 0.06
-0.39 units on a scale
Interval -0.83 to 0.05
-0.71 units on a scale
Interval -1.17 to -0.25
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
Week 60
-0.78 units on a scale
Interval -1.22 to -0.34
-0.75 units on a scale
Interval -13.46 to 11.96
-0.31 units on a scale
Interval -4.28 to 3.66
-0.58 units on a scale
Interval -1.3 to 0.15
-0.48 units on a scale
Interval -1.77 to 0.82
-0.72 units on a scale
Interval -1.61 to 0.18

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=11 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 18
-16.04 mg/L
Interval -24.13 to -7.95
5.34 mg/L
Interval -9.84 to 20.53
-0.96 mg/L
Interval -6.2 to 4.28
-14.85 mg/L
Interval -34.27 to 4.57
-11.48 mg/L
Interval -16.88 to -6.07
-10.00 mg/L
Interval -28.36 to 8.35
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 24
-15.08 mg/L
Interval -23.26 to -6.9
-0.20 mg/L
Interval -15.16 to 14.76
-2.18 mg/L
Interval -4.3 to -0.06
-15.09 mg/L
Interval -38.53 to 8.34
-9.48 mg/L
Interval -15.35 to -3.6
-13.16 mg/L
Interval -32.31 to 5.99
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 30
-16.61 mg/L
Interval -27.35 to -5.88
-6.00 mg/L
Interval -24.37 to 12.36
-1.66 mg/L
Interval -4.91 to 1.59
-17.11 mg/L
Interval -44.18 to 9.95
-9.55 mg/L
Interval -14.24 to -4.85
-16.22 mg/L
Interval -28.83 to -3.61
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 36
-13.88 mg/L
Interval -23.43 to -4.32
-12.43 mg/L
Interval -27.58 to 2.73
-1.58 mg/L
Interval -11.33 to 8.18
-13.61 mg/L
Interval -34.5 to 7.28
-7.76 mg/L
Interval -13.95 to -1.56
-18.34 mg/L
Interval -37.3 to 0.62
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 48
-16.41 mg/L
Interval -28.14 to -4.69
-18.38 mg/L
Interval -50.37 to 13.6
-5.99 mg/L
Interval -17.43 to 5.45
-20.18 mg/L
Interval -49.36 to 9.0
-7.22 mg/L
Interval -14.57 to 0.14
-18.30 mg/L
Interval -36.16 to -0.44
Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
Week 60
-25.69 mg/L
Interval -45.41 to -5.98
-31.46 mg/L
Interval -288.63 to 225.71
-3.98 mg/L
Interval -116.05 to 108.09
-25.58 mg/L
Interval -67.98 to 16.83
-3.34 mg/L
Interval -23.18 to 16.5
-12.47 mg/L
Interval -33.61 to 8.67

SECONDARY outcome

Timeframe: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data

Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=25 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=15 Participants
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=7 Participants
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=10 Participants
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=17 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=8 Participants
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 18
-4.27 units on a scale
Interval -5.56 to -2.99
-2.27 units on a scale
Interval -3.69 to -0.84
-2.14 units on a scale
Interval -4.99 to 0.7
-3.40 units on a scale
Interval -6.02 to -0.78
-5.29 units on a scale
Interval -6.54 to -4.05
-2.38 units on a scale
Interval -4.65 to -0.1
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 24
-4.48 units on a scale
Interval -5.52 to -3.44
-2.64 units on a scale
Interval -3.81 to -1.47
-3.29 units on a scale
Interval -5.89 to -0.69
-3.70 units on a scale
Interval -5.21 to -2.19
-4.88 units on a scale
Interval -6.43 to -3.32
-3.50 units on a scale
Interval -5.5 to -1.5
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 30
-4.36 units on a scale
Interval -5.83 to -2.9
-2.23 units on a scale
Interval -4.28 to -0.18
-1.20 units on a scale
Interval -2.82 to 0.42
-4.20 units on a scale
Interval -5.66 to -2.74
-4.53 units on a scale
Interval -5.75 to -3.32
-3.13 units on a scale
Interval -5.55 to -0.7
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 36
-4.43 units on a scale
Interval -5.95 to -2.92
-3.38 units on a scale
Interval -5.74 to -1.01
-1.00 units on a scale
Interval -5.3 to 3.3
-4.00 units on a scale
Interval -5.39 to -2.61
-5.55 units on a scale
Interval -6.8 to -4.29
-3.00 units on a scale
Interval -6.18 to 0.18
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 48
-5.47 units on a scale
Interval -6.64 to -4.3
-3.33 units on a scale
Interval -6.49 to -0.17
-1.00 units on a scale
Interval -7.57 to 5.57
-4.13 units on a scale
Interval -6.67 to -1.58
-5.38 units on a scale
Interval -7.1 to -3.65
-3.67 units on a scale
Interval -6.9 to -0.44
Change in Morning Stiffness Severity From Baseline of Study M16-063
Week 60
-4.89 units on a scale
Interval -6.54 to -3.24
-4.50 units on a scale
Interval -23.56 to 14.56
-3.00 units on a scale
Not calculable/estimable because standard deviation = 0
-4.40 units on a scale
Interval -6.66 to -2.14
-4.80 units on a scale
Interval -7.19 to -2.41
-3.00 units on a scale
Interval -5.25 to -0.75

Adverse Events

ABBV-599 in M16-063/ABBV-599 in M16-763

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

ABBV-105 60 mg/UPA Placebo

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

ABBV-105 20 mg/UPA Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

ABBV-105 5 mg/UPA Placebo

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

UPA 15 mg/ABBV-105 Placebo

Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths

Placebo in M16-063/ABBV-599 in M16-763

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=12 participants at risk
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 participants at risk
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 participants at risk
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Injury, poisoning and procedural complications
PERIPROSTHETIC FRACTURE
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763

Other adverse events

Other adverse events
Measure
ABBV-599 in M16-063/ABBV-599 in M16-763
n=28 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA Placebo
n=16 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA Placebo
n=12 participants at risk
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA Placebo
n=12 participants at risk
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 Placebo
n=20 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
n=9 participants at risk
Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Blood and lymphatic system disorders
ANAEMIA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Gastrointestinal disorders
DIARRHOEA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Gastrointestinal disorders
NAUSEA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Gastrointestinal disorders
VOMITING
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
ASTHENIA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
DRUG INTOLERANCE
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
DRUG WITHDRAWAL SYNDROME
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
INFLUENZA LIKE ILLNESS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
NON-CARDIAC CHEST PAIN
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
General disorders
PYREXIA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
BRONCHITIS
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
EAR INFECTION
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
GASTROENTERITIS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
NASOPHARYNGITIS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
ORAL CANDIDIASIS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
TOOTH INFECTION
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
10.7%
3/28 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
URETHRITIS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Infections and infestations
URINARY TRACT INFECTION
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Injury, poisoning and procedural complications
FALL
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Investigations
URINE ANALYSIS ABNORMAL
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Metabolism and nutrition disorders
DIABETES MELLITUS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Metabolism and nutrition disorders
HYPERGLYCAEMIA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Musculoskeletal and connective tissue disorders
JOINT SWELLING
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
25.0%
4/16 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Nervous system disorders
DIZZINESS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Nervous system disorders
HEADACHE
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Nervous system disorders
TREMOR
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Psychiatric disorders
ANXIETY
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Psychiatric disorders
DEPRESSION
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Renal and urinary disorders
RENAL CYST
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/16 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Skin and subcutaneous tissue disorders
DERMATITIS
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
Vascular disorders
HYPERTENSION
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
6.2%
1/16 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

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