Trial Outcomes & Findings for A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State (NCT NCT04451772)
NCT ID: NCT04451772
Last Updated: 2025-01-14
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 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 events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
Results posted on
2025-01-14
Participant Flow
Full Analysis Set (FAS): all participants who received at least 1 dose of study drug in Study M20-186. Participants are grouped according to treatment sequence as randomized for Studies M19-130 and M20-186.
Participant milestones
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
35
|
19
|
25
|
14
|
|
Overall Study
COMPLETED
|
41
|
38
|
31
|
6
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
4
|
13
|
24
|
13
|
Reasons for withdrawal
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
2
|
1
|
1
|
0
|
|
Overall Study
Other, not specified
|
1
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Sponsor decision based on interim analysis data review
|
0
|
0
|
0
|
11
|
23
|
9
|
Baseline Characteristics
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Baseline characteristics by cohort
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
n=19 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
n=25 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
n=14 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 10.52 • n=4 Participants
|
41.2 years
STANDARD_DEVIATION 11.60 • n=21 Participants
|
42.5 years
STANDARD_DEVIATION 11.57 • n=8 Participants
|
41.6 years
STANDARD_DEVIATION 11.50 • n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
175 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 daysPopulation: Safety analysis set: all participants who received at least 1 dose of study drug in Study M20-186, grouped according to treatment sequence actually received
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 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 events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
Outcome measures
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
n=19 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
n=25 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
n=14 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Any TEAE
|
34 participants
|
31 participants
|
30 participants
|
11 participants
|
11 participants
|
7 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
TESAE
|
5 participants
|
5 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis. When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline in Study M19-130: * ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
Outcome measures
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=46 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 56
|
71.1 percentage of participants
Interval 57.9 to 84.4
|
76.1 percentage of participants
Interval 63.8 to 88.4
|
54.3 percentage of participants
Interval 37.8 to 70.8
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 64
|
70.5 percentage of participants
Interval 57.0 to 83.9
|
75.6 percentage of participants
Interval 63.0 to 88.1
|
58.8 percentage of participants
Interval 42.3 to 75.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 72
|
80.5 percentage of participants
Interval 68.4 to 92.6
|
88.9 percentage of participants
Interval 79.7 to 98.1
|
64.7 percentage of participants
Interval 48.6 to 80.8
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 80
|
75.0 percentage of participants
Interval 61.6 to 88.4
|
82.2 percentage of participants
Interval 71.1 to 93.4
|
57.6 percentage of participants
Interval 40.7 to 74.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 88
|
82.5 percentage of participants
Interval 70.7 to 94.3
|
85.7 percentage of participants
Interval 75.1 to 96.3
|
48.5 percentage of participants
Interval 31.4 to 65.5
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 96
|
82.9 percentage of participants
Interval 71.4 to 94.4
|
76.9 percentage of participants
Interval 63.7 to 90.1
|
62.5 percentage of participants
Interval 45.7 to 79.3
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Week 104
|
85.4 percentage of participants
Interval 74.5 to 96.2
|
82.1 percentage of participants
Interval 70.0 to 94.1
|
61.3 percentage of participants
Interval 44.1 to 78.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis. When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \[PhGA\], \< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Outcome measures
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=46 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 56
|
73.3 percentage of participants
Interval 60.4 to 86.3
|
67.4 percentage of participants
Interval 53.8 to 80.9
|
60.0 percentage of participants
Interval 43.8 to 76.2
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 64
|
75.0 percentage of participants
Interval 62.2 to 87.8
|
84.4 percentage of participants
Interval 73.9 to 95.0
|
55.9 percentage of participants
Interval 39.2 to 72.6
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 72
|
73.2 percentage of participants
Interval 59.6 to 86.7
|
88.9 percentage of participants
Interval 79.7 to 98.1
|
61.8 percentage of participants
Interval 45.4 to 78.1
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 80
|
70.0 percentage of participants
Interval 55.8 to 84.2
|
77.8 percentage of participants
Interval 65.6 to 89.9
|
57.6 percentage of participants
Interval 40.7 to 74.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 88
|
80.0 percentage of participants
Interval 67.6 to 92.4
|
85.7 percentage of participants
Interval 75.1 to 96.3
|
57.6 percentage of participants
Interval 40.7 to 74.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 96
|
78.0 percentage of participants
Interval 65.4 to 90.7
|
76.9 percentage of participants
Interval 63.7 to 90.1
|
59.4 percentage of participants
Interval 42.4 to 76.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Week 104
|
78.0 percentage of participants
Interval 65.4 to 90.7
|
69.2 percentage of participants
Interval 54.7 to 83.7
|
54.8 percentage of participants
Interval 37.3 to 72.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis. When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses..
Participants'current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
Outcome measures
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 64
|
-4.2 mg
Standard Deviation 5.51
|
-3.7 mg
Standard Deviation 5.97
|
-5.0 mg
Standard Deviation 6.87
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 56
|
-3.9 mg
Standard Deviation 5.96
|
-3.5 mg
Standard Deviation 5.99
|
-4.9 mg
Standard Deviation 6.99
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 72
|
-4.0 mg
Standard Deviation 6.59
|
-4.9 mg
Standard Deviation 7.23
|
-5.2 mg
Standard Deviation 6.88
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 80
|
-5.1 mg
Standard Deviation 5.96
|
-4.4 mg
Standard Deviation 8.05
|
-5.2 mg
Standard Deviation 6.88
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 88
|
-5.5 mg
Standard Deviation 5.83
|
-5.2 mg
Standard Deviation 6.02
|
-6.2 mg
Standard Deviation 7.04
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 96
|
-5.5 mg
Standard Deviation 5.88
|
-5.7 mg
Standard Deviation 5.78
|
-7.3 mg
Standard Deviation 6.54
|
—
|
—
|
—
|
|
Change From Baseline in Daily Prednisone Dose Over Time
Week 104
|
-5.8 mg
Standard Deviation 6.02
|
-5.5 mg
Standard Deviation 5.65
|
-7.7 mg
Standard Deviation 6.64
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 56 through Week 104Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis. When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Outcome measures
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 Participants
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 Participants
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
Mild/Moderate
|
0.62 Events per patient-year
Interval 0.39 to 0.84
|
1.41 Events per patient-year
Interval 1.06 to 1.75
|
1.39 Events per patient-year
Interval 0.99 to 1.78
|
—
|
—
|
—
|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
Severe
|
0.00 Events per patient-year
Interval 0.0 to 0.0
|
0.04 Events per patient-year
Interval -0.02 to 0.1
|
0.17 Events per patient-year
Interval 0.03 to 0.31
|
—
|
—
|
—
|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
Overall
|
0.62 Events per patient-year
Interval 0.39 to 0.84
|
1.45 Events per patient-year
Interval 1.1 to 1.8
|
1.56 Events per patient-year
Interval 1.14 to 1.97
|
—
|
—
|
—
|
Adverse Events
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
n=19 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
n=25 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
n=14 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
OEDEMA PERIPHERAL
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
SEROSITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
COVID-19
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
MIGRAINE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
Other adverse events
| Measure |
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose
n=45 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg
n=47 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 High Dose
n=35 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) -> ABBV-599 Low Dose
n=19 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib 60 mg/Upadacitinib Placebo -> Elsubrutinib 60 mg/Upadacitinib Placebo
n=25 participants at risk
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
|
Elsubrutinib Placebo/Upadacitinib Placebo -> ABBV-599 Low Dose
n=14 participants at risk
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Congenital, familial and genetic disorders
PYLORIC STENOSIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Congenital, familial and genetic disorders
TYPE V HYPERLIPIDAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Eye disorders
CATARACT
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Eye disorders
DRY EYE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
GASTRITIS
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
LARGE INTESTINAL ULCER
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
1/45 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
ASTHENIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
GRANULOMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
OEDEMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
General disorders
PYREXIA
|
2.2%
1/45 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
6.4%
3/47 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
COVID-19
|
17.8%
8/45 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
23.4%
11/47 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
20.0%
7/35 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
GASTROENTERITIS
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
HERPES ZOSTER
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
MYCOPLASMA INFECTION
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.7%
3/45 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.3%
2/47 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
ORAL HERPES
|
4.4%
2/45 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.3%
2/47 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
TINEA VERSICOLOUR
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.9%
4/45 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
6.4%
3/47 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
17.1%
6/35 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
15.6%
7/45 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
6.4%
3/47 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
17.1%
6/35 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
15.8%
3/19 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
IMMUNISATION REACTION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.2%
1/45 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
10.5%
2/19 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Musculoskeletal and connective tissue disorders
CONNECTIVE TISSUE DISORDER
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
DIZZINESS
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
HEADACHE
|
4.4%
2/45 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
8.6%
3/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Renal and urinary disorders
LUPUS NEPHRITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Renal and urinary disorders
PROTEINURIA
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERSENSITIVITY PNEUMONITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS VASCULITIS
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.9%
4/45 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Vascular disorders
HYPERTENSION
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
10.5%
2/19 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/47 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
5.3%
1/19 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER