Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD) (NCT NCT03781167)
NCT ID: NCT03781167
Last Updated: 2023-10-23
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
COMPLETED
PHASE3
244 participants
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
2023-10-23
Participant Flow
All enrolled participants
Participant milestones
| Measure |
ABBV-951 Low Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
113
|
|
Overall Study
COMPLETED
|
84
|
65
|
|
Overall Study
NOT COMPLETED
|
47
|
48
|
Reasons for withdrawal
| Measure |
ABBV-951 Low Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
|---|---|---|
|
Overall Study
Adverse Event
|
23
|
25
|
|
Overall Study
Withdrew consent
|
16
|
12
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
5
|
|
Overall Study
Difficulty with drug delivery system
|
2
|
3
|
|
Overall Study
Other, not specified
|
2
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.54 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any TEAE
|
121 Participants
|
109 Participants
|
230 Participants
|
|
Number of Participants With Adverse Events
TESAE
|
32 Participants
|
31 Participants
|
63 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest
Infusion site infections
|
42 Participants
|
44 Participants
|
86 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Infusion site reactions
|
103 Participants
|
97 Participants
|
200 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Hallucinations/psychosis
|
32 Participants
|
29 Participants
|
61 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Falls and associated injuries
|
37 Participants
|
37 Participants
|
74 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Polyneuropathy (peripheral neuropathy)
|
14 Participants
|
13 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Weight loss
|
12 Participants
|
15 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Somnolence
|
9 Participants
|
3 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE).
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
|
10 Participants
|
15 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=128 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=241 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Hematocrit (Hematology): Change From Baseline to End of Study
Week 6
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.031
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.029
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.030
|
|
Hematocrit (Hematology): Change From Baseline to End of Study
Week 39
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.028
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.029
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.028
|
|
Hematocrit (Hematology): Change From Baseline to End of Study
Week 52
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.029
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.028
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.029
|
|
Hematocrit (Hematology): Change From Baseline to End of Study
Week 26
|
-0.01 proportion of red blood cells in blood
Standard Deviation 0.030
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.026
|
-0.02 proportion of red blood cells in blood
Standard Deviation 0.028
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Hemoglobin (Hematology): Change From Baseline to End of Study
Week 6
|
-5.00 g/L
Standard Deviation 8.308
|
-6.82 g/L
Standard Deviation 9.222
|
-5.89 g/L
Standard Deviation 8.789
|
|
Hemoglobin (Hematology): Change From Baseline to End of Study
Week 26
|
-5.42 g/L
Standard Deviation 9.296
|
-4.48 g/L
Standard Deviation 7.502
|
-4.98 g/L
Standard Deviation 8.482
|
|
Hemoglobin (Hematology): Change From Baseline to End of Study
Week 39
|
-5.74 g/L
Standard Deviation 8.430
|
-6.58 g/L
Standard Deviation 8.601
|
-6.11 g/L
Standard Deviation 8.480
|
|
Hemoglobin (Hematology): Change From Baseline to End of Study
Week 52
|
-7.96 g/L
Standard Deviation 8.862
|
-5.80 g/L
Standard Deviation 9.308
|
-6.99 g/L
Standard Deviation 9.091
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Week 26
|
-0.12 cells*10^12/L
Standard Deviation 0.295
|
-0.13 cells*10^12/L
Standard Deviation 0.273
|
-0.13 cells*10^12/L
Standard Deviation 0.284
|
|
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Week 39
|
-0.14 cells*10^12/L
Standard Deviation 0.271
|
-0.19 cells*10^12/L
Standard Deviation 0.290
|
-0.17 cells*10^12/L
Standard Deviation 0.279
|
|
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Week 52
|
-0.21 cells*10^12/L
Standard Deviation 0.291
|
-0.16 cells*10^12/L
Standard Deviation 0.293
|
-0.19 cells*10^12/L
Standard Deviation 0.292
|
|
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Week 6
|
-0.15 cells*10^12/L
Standard Deviation 0.261
|
-0.21 cells*10^12/L
Standard Deviation 0.296
|
-0.18 cells*10^12/L
Standard Deviation 0.280
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Week 6
|
0.02 cells*10^9/L
Standard Deviation 1.705
|
0.32 cells*10^9/L
Standard Deviation 2.120
|
0.17 cells*10^9/L
Standard Deviation 1.919
|
|
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Week 39
|
0.35 cells*10^9/L
Standard Deviation 4.014
|
0.38 cells*10^9/L
Standard Deviation 1.670
|
0.36 cells*10^9/L
Standard Deviation 3.202
|
|
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Week 52
|
-0.08 cells*10^9/L
Standard Deviation 2.027
|
-0.04 cells*10^9/L
Standard Deviation 1.568
|
-0.06 cells*10^9/L
Standard Deviation 1.829
|
|
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Week 26
|
0.12 cells*10^9/L
Standard Deviation 1.892
|
0.22 cells*10^9/L
Standard Deviation 2.990
|
0.17 cells*10^9/L
Standard Deviation 2.460
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Neutrophils (Hematology): Change From Baseline to End of Study
Week 6
|
0.01 cells*10^9/L
Standard Deviation 1.720
|
0.33 cells*10^9/L
Standard Deviation 2.102
|
0.17 cells*10^9/L
Standard Deviation 1.917
|
|
Neutrophils (Hematology): Change From Baseline to End of Study
Week 26
|
-0.03 cells*10^9/L
Standard Deviation 1.813
|
143.08 cells*10^9/L
Standard Deviation 1133.988
|
67.25 cells*10^9/L
Standard Deviation 777.558
|
|
Neutrophils (Hematology): Change From Baseline to End of Study
Week 39
|
-0.23 cells*10^9/L
Standard Deviation 2.380
|
0.18 cells*10^9/L
Standard Deviation 1.635
|
-0.05 cells*10^9/L
Standard Deviation 2.089
|
|
Neutrophils (Hematology): Change From Baseline to End of Study
Week 52
|
-0.14 cells*10^9/L
Standard Deviation 1.986
|
-0.04 cells*10^9/L
Standard Deviation 1.498
|
-0.10 cells*10^9/L
Standard Deviation 1.778
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Lymphocytes (Hematology): Change From Baseline to End of Study
Week 6
|
0.06 cells*10^9/L
Standard Deviation 0.305
|
-0.07 cells*10^9/L
Standard Deviation 0.326
|
0.00 cells*10^9/L
Standard Deviation 0.321
|
|
Lymphocytes (Hematology): Change From Baseline to End of Study
Week 26
|
0.09 cells*10^9/L
Standard Deviation 0.331
|
13.92 cells*10^9/L
Standard Deviation 110.588
|
6.59 cells*10^9/L
Standard Deviation 75.823
|
|
Lymphocytes (Hematology): Change From Baseline to End of Study
Week 39
|
0.03 cells*10^9/L
Standard Deviation 0.394
|
0.04 cells*10^9/L
Standard Deviation 0.312
|
0.03 cells*10^9/L
Standard Deviation 0.359
|
|
Lymphocytes (Hematology): Change From Baseline to End of Study
Week 52
|
0.04 cells*10^9/L
Standard Deviation 0.394
|
-0.05 cells*10^9/L
Standard Deviation 0.294
|
0.00 cells*10^9/L
Standard Deviation 0.354
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Monocytes (Hematology): Change From Baseline to End of Study
Week 52
|
0.00 cells*10^9/L
Standard Deviation 0.109
|
0.01 cells*10^9/L
Standard Deviation 0.132
|
0.00 cells*10^9/L
Standard Deviation 0.119
|
|
Monocytes (Hematology): Change From Baseline to End of Study
Week 6
|
0.01 cells*10^9/L
Standard Deviation 0.127
|
0.01 cells*10^9/L
Standard Deviation 0.123
|
0.01 cells*10^9/L
Standard Deviation 0.125
|
|
Monocytes (Hematology): Change From Baseline to End of Study
Week 26
|
0.02 cells*10^9/L
Standard Deviation 0.095
|
17.43 cells*10^9/L
Standard Deviation 138.498
|
8.21 cells*10^9/L
Standard Deviation 94.963
|
|
Monocytes (Hematology): Change From Baseline to End of Study
Week 39
|
0.02 cells*10^9/L
Standard Deviation 0.120
|
0.03 cells*10^9/L
Standard Deviation 0.122
|
0.02 cells*10^9/L
Standard Deviation 0.120
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=242 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Week 6
|
4.59 cells*10^9/L
Standard Deviation 36.489
|
0.39 cells*10^9/L
Standard Deviation 40.844
|
2.54 cells*10^9/L
Standard Deviation 38.635
|
|
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Week 52
|
-3.41 cells*10^9/L
Standard Deviation 41.120
|
-10.63 cells*10^9/L
Standard Deviation 44.537
|
-6.58 cells*10^9/L
Standard Deviation 42.628
|
|
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Week 26
|
-1.68 cells*10^9/L
Standard Deviation 43.279
|
-10.39 cells*10^9/L
Standard Deviation 43.757
|
-5.74 cells*10^9/L
Standard Deviation 43.556
|
|
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Week 39
|
-3.90 cells*10^9/L
Standard Deviation 43.848
|
-7.29 cells*10^9/L
Standard Deviation 49.222
|
-5.37 cells*10^9/L
Standard Deviation 46.084
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Week 6
|
-0.09 picograms
Standard Deviation 0.822
|
-0.15 picograms
Standard Deviation 0.825
|
-0.12 picograms
Standard Deviation 0.821
|
|
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Week 26
|
-0.38 picograms
Standard Deviation 1.033
|
0.05 picograms
Standard Deviation 1.078
|
-0.18 picograms
Standard Deviation 1.072
|
|
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Week 39
|
-0.34 picograms
Standard Deviation 1.205
|
-0.08 picograms
Standard Deviation 0.978
|
-0.22 picograms
Standard Deviation 1.114
|
|
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Week 52
|
-0.36 picograms
Standard Deviation 1.124
|
-0.07 picograms
Standard Deviation 1.142
|
-0.23 picograms
Standard Deviation 1.137
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=128 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=241 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Week 6
|
2.15 g/L
Standard Deviation 11.689
|
1.78 g/L
Standard Deviation 10.870
|
1.97 g/L
Standard Deviation 11.264
|
|
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Week 26
|
-1.30 g/L
Standard Deviation 14.844
|
2.17 g/L
Standard Deviation 15.741
|
0.31 g/L
Standard Deviation 15.306
|
|
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Week 39
|
-2.13 g/L
Standard Deviation 13.677
|
-2.64 g/L
Standard Deviation 14.826
|
-2.37 g/L
Standard Deviation 14.161
|
|
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Week 52
|
-0.16 g/L
Standard Deviation 12.609
|
0.18 g/L
Standard Deviation 13.684
|
0.00 g/L
Standard Deviation 13.074
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Week 52
|
0.10 seconds
Standard Deviation 0.889
|
-0.22 seconds
Standard Deviation 3.703
|
-0.04 seconds
Standard Deviation 2.483
|
|
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Week 6
|
0.03 seconds
Standard Deviation 0.480
|
-0.09 seconds
Standard Deviation 2.556
|
-0.03 seconds
Standard Deviation 1.803
|
|
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Week 26
|
-0.08 seconds
Standard Deviation 1.026
|
-0.36 seconds
Standard Deviation 3.187
|
-0.20 seconds
Standard Deviation 2.261
|
|
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Week 39
|
0.10 seconds
Standard Deviation 0.569
|
-0.21 seconds
Standard Deviation 3.396
|
-0.03 seconds
Standard Deviation 2.239
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Week 6
|
-0.27 seconds
Standard Deviation 2.151
|
0.55 seconds
Standard Deviation 2.483
|
0.13 seconds
Standard Deviation 2.347
|
|
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Week 26
|
-0.02 seconds
Standard Deviation 1.898
|
0.48 seconds
Standard Deviation 1.932
|
0.20 seconds
Standard Deviation 1.922
|
|
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Week 39
|
0.14 seconds
Standard Deviation 1.556
|
0.67 seconds
Standard Deviation 3.672
|
0.36 seconds
Standard Deviation 2.661
|
|
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Week 52
|
-0.09 seconds
Standard Deviation 2.156
|
0.88 seconds
Standard Deviation 2.992
|
0.32 seconds
Standard Deviation 2.573
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
0.41 mmol/L
Standard Deviation 1.852
|
0.05 mmol/L
Standard Deviation 1.659
|
0.25 mmol/L
Standard Deviation 1.773
|
|
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
0.16 mmol/L
Standard Deviation 1.836
|
0.15 mmol/L
Standard Deviation 1.342
|
0.16 mmol/L
Standard Deviation 1.636
|
|
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
0.02 mmol/L
Standard Deviation 1.348
|
-0.01 mmol/L
Standard Deviation 1.560
|
0.00 mmol/L
Standard Deviation 1.450
|
|
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
0.21 mmol/L
Standard Deviation 1.489
|
0.17 mmol/L
Standard Deviation 1.600
|
0.19 mmol/L
Standard Deviation 1.535
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-4.45 µmol/L
Standard Deviation 9.227
|
-5.67 µmol/L
Standard Deviation 10.725
|
-5.04 µmol/L
Standard Deviation 9.968
|
|
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-4.78 µmol/L
Standard Deviation 11.446
|
-5.21 µmol/L
Standard Deviation 9.941
|
-4.96 µmol/L
Standard Deviation 10.785
|
|
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-2.71 µmol/L
Standard Deviation 10.478
|
-4.07 µmol/L
Standard Deviation 12.074
|
-3.33 µmol/L
Standard Deviation 11.213
|
|
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-1.47 µmol/L
Standard Deviation 12.414
|
-4.02 µmol/L
Standard Deviation 10.182
|
-2.58 µmol/L
Standard Deviation 11.527
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
2.52 U/L
Standard Deviation 56.209
|
-11.01 U/L
Standard Deviation 94.662
|
-4.01 U/L
Standard Deviation 77.285
|
|
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
30.39 U/L
Standard Deviation 125.044
|
-16.55 U/L
Standard Deviation 85.305
|
10.17 U/L
Standard Deviation 111.783
|
|
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
5.61 U/L
Standard Deviation 51.627
|
-15.44 U/L
Standard Deviation 62.435
|
-3.83 U/L
Standard Deviation 57.480
|
|
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
8.40 U/L
Standard Deviation 96.021
|
-9.67 U/L
Standard Deviation 75.655
|
0.66 U/L
Standard Deviation 88.002
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.85 µmol/L
Standard Deviation 3.420
|
-0.15 µmol/L
Standard Deviation 3.167
|
-0.51 µmol/L
Standard Deviation 3.311
|
|
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.43 µmol/L
Standard Deviation 3.535
|
0.28 µmol/L
Standard Deviation 2.814
|
-0.11 µmol/L
Standard Deviation 3.240
|
|
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.71 µmol/L
Standard Deviation 2.881
|
0.31 µmol/L
Standard Deviation 3.754
|
-0.27 µmol/L
Standard Deviation 3.313
|
|
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.30 µmol/L
Standard Deviation 3.673
|
-0.15 µmol/L
Standard Deviation 3.250
|
-0.24 µmol/L
Standard Deviation 3.485
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-8.94 U/L
Standard Deviation 8.928
|
-11.28 U/L
Standard Deviation 10.053
|
-10.07 U/L
Standard Deviation 9.535
|
|
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-8.95 U/L
Standard Deviation 9.869
|
-11.66 U/L
Standard Deviation 11.294
|
-10.16 U/L
Standard Deviation 10.579
|
|
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-9.70 U/L
Standard Deviation 9.145
|
-10.09 U/L
Standard Deviation 13.476
|
-9.87 U/L
Standard Deviation 11.175
|
|
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-9.37 U/L
Standard Deviation 10.347
|
-12.11 U/L
Standard Deviation 9.947
|
-10.56 U/L
Standard Deviation 10.227
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-1.89 U/L
Standard Deviation 4.881
|
-2.21 U/L
Standard Deviation 6.163
|
-2.05 U/L
Standard Deviation 5.524
|
|
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.69 U/L
Standard Deviation 8.569
|
-2.56 U/L
Standard Deviation 7.013
|
-1.52 U/L
Standard Deviation 7.943
|
|
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-1.38 U/L
Standard Deviation 6.714
|
-1.17 U/L
Standard Deviation 7.036
|
-1.29 U/L
Standard Deviation 6.827
|
|
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.81 U/L
Standard Deviation 6.576
|
-0.82 U/L
Standard Deviation 7.794
|
-0.81 U/L
Standard Deviation 7.095
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=129 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=109 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=238 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-6.57 U/L
Standard Deviation 26.734
|
-8.58 U/L
Standard Deviation 23.626
|
-7.55 U/L
Standard Deviation 25.213
|
|
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-1.66 U/L
Standard Deviation 23.894
|
-4.91 U/L
Standard Deviation 23.613
|
-3.14 U/L
Standard Deviation 23.725
|
|
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-2.17 U/L
Standard Deviation 25.010
|
-2.02 U/L
Standard Deviation 26.431
|
-2.10 U/L
Standard Deviation 25.526
|
|
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
0.14 U/L
Standard Deviation 22.788
|
3.32 U/L
Standard Deviation 26.413
|
1.41 U/L
Standard Deviation 24.237
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-1.92 U/L
Standard Deviation 10.860
|
-4.67 U/L
Standard Deviation 12.516
|
-3.10 U/L
Standard Deviation 11.631
|
|
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
1.69 U/L
Standard Deviation 23.235
|
-3.09 U/L
Standard Deviation 14.538
|
-0.37 U/L
Standard Deviation 20.031
|
|
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-1.07 U/L
Standard Deviation 9.516
|
-3.13 U/L
Standard Deviation 9.393
|
-2.06 U/L
Standard Deviation 9.489
|
|
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-1.47 U/L
Standard Deviation 11.487
|
-5.02 U/L
Standard Deviation 15.370
|
-3.07 U/L
Standard Deviation 13.450
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-1.91 U/L
Standard Deviation 12.394
|
-4.56 U/L
Standard Deviation 12.340
|
-3.19 U/L
Standard Deviation 12.408
|
|
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
1.68 U/L
Standard Deviation 18.995
|
-2.86 U/L
Standard Deviation 14.157
|
-0.39 U/L
Standard Deviation 17.051
|
|
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-2.28 U/L
Standard Deviation 12.252
|
-5.02 U/L
Standard Deviation 16.088
|
-3.46 U/L
Standard Deviation 14.049
|
|
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
0.55 U/L
Standard Deviation 18.637
|
-1.54 U/L
Standard Deviation 13.796
|
-0.35 U/L
Standard Deviation 16.697
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.55 mmol/L
Standard Deviation 2.774
|
-0.84 mmol/L
Standard Deviation 2.164
|
-0.67 mmol/L
Standard Deviation 2.522
|
|
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.52 mmol/L
Standard Deviation 3.168
|
-1.06 mmol/L
Standard Deviation 2.592
|
-0.78 mmol/L
Standard Deviation 2.911
|
|
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.35 mmol/L
Standard Deviation 3.173
|
-1.26 mmol/L
Standard Deviation 2.744
|
-0.76 mmol/L
Standard Deviation 3.010
|
|
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.90 mmol/L
Standard Deviation 2.984
|
-0.68 mmol/L
Standard Deviation 2.772
|
-0.81 mmol/L
Standard Deviation 2.887
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.02 mmol/L
Standard Deviation 0.335
|
-0.08 mmol/L
Standard Deviation 0.330
|
-0.05 mmol/L
Standard Deviation 0.333
|
|
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
0.01 mmol/L
Standard Deviation 0.367
|
0.00 mmol/L
Standard Deviation 0.373
|
0.00 mmol/L
Standard Deviation 0.368
|
|
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.01 mmol/L
Standard Deviation 0.389
|
-0.09 mmol/L
Standard Deviation 0.382
|
-0.04 mmol/L
Standard Deviation 0.387
|
|
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.10 mmol/L
Standard Deviation 0.369
|
-0.03 mmol/L
Standard Deviation 0.338
|
-0.07 mmol/L
Standard Deviation 0.357
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.03 mmol/L
Standard Deviation 0.080
|
-0.04 mmol/L
Standard Deviation 0.091
|
-0.03 mmol/L
Standard Deviation 0.085
|
|
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.02 mmol/L
Standard Deviation 0.079
|
-0.04 mmol/L
Standard Deviation 0.086
|
-0.03 mmol/L
Standard Deviation 0.083
|
|
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.04 mmol/L
Standard Deviation 0.091
|
-0.05 mmol/L
Standard Deviation 0.087
|
-0.05 mmol/L
Standard Deviation 0.089
|
|
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.06 mmol/L
Standard Deviation 0.084
|
-0.04 mmol/L
Standard Deviation 0.092
|
-0.05 mmol/L
Standard Deviation 0.088
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
0.09 mmol/L
Standard Deviation 0.169
|
0.08 mmol/L
Standard Deviation 0.172
|
0.08 mmol/L
Standard Deviation 0.170
|
|
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
0.08 mmol/L
Standard Deviation 0.173
|
0.08 mmol/L
Standard Deviation 0.168
|
0.08 mmol/L
Standard Deviation 0.170
|
|
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
0.09 mmol/L
Standard Deviation 0.182
|
0.09 mmol/L
Standard Deviation 0.170
|
0.09 mmol/L
Standard Deviation 0.176
|
|
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
0.07 mmol/L
Standard Deviation 0.165
|
0.08 mmol/L
Standard Deviation 0.155
|
0.08 mmol/L
Standard Deviation 0.160
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-28.36 µmol/L
Standard Deviation 51.219
|
-37.43 µmol/L
Standard Deviation 37.302
|
-32.73 µmol/L
Standard Deviation 45.163
|
|
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-16.66 µmol/L
Standard Deviation 60.922
|
-32.91 µmol/L
Standard Deviation 34.446
|
-24.01 µmol/L
Standard Deviation 51.163
|
|
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-13.55 µmol/L
Standard Deviation 57.830
|
-35.80 µmol/L
Standard Deviation 40.965
|
-23.18 µmol/L
Standard Deviation 52.213
|
|
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-15.27 µmol/L
Standard Deviation 56.459
|
-31.23 µmol/L
Standard Deviation 29.780
|
-22.15 µmol/L
Standard Deviation 47.380
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.37 mmol/L
Standard Deviation 0.688
|
-0.57 mmol/L
Standard Deviation 0.556
|
-0.47 mmol/L
Standard Deviation 0.634
|
|
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.19 mmol/L
Standard Deviation 0.657
|
-0.31 mmol/L
Standard Deviation 0.661
|
-0.25 mmol/L
Standard Deviation 0.659
|
|
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.33 mmol/L
Standard Deviation 0.565
|
-0.41 mmol/L
Standard Deviation 0.552
|
-0.36 mmol/L
Standard Deviation 0.559
|
|
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.31 mmol/L
Standard Deviation 0.660
|
-0.25 mmol/L
Standard Deviation 0.594
|
-0.29 mmol/L
Standard Deviation 0.630
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-1.65 g/L
Standard Deviation 2.782
|
-1.95 g/L
Standard Deviation 2.885
|
-1.79 g/L
Standard Deviation 2.829
|
|
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-1.31 g/L
Standard Deviation 2.541
|
-1.14 g/L
Standard Deviation 2.558
|
-1.23 g/L
Standard Deviation 2.541
|
|
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-1.75 g/L
Standard Deviation 2.782
|
-1.56 g/L
Standard Deviation 2.507
|
-1.67 g/L
Standard Deviation 2.658
|
|
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-1.96 g/L
Standard Deviation 2.949
|
-1.02 g/L
Standard Deviation 3.205
|
-1.55 g/L
Standard Deviation 3.086
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.39 mmol/L
Standard Deviation 1.186
|
-0.39 mmol/L
Standard Deviation 1.438
|
-0.39 mmol/L
Standard Deviation 1.311
|
|
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.37 mmol/L
Standard Deviation 1.271
|
-0.14 mmol/L
Standard Deviation 1.486
|
-0.27 mmol/L
Standard Deviation 1.373
|
|
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.33 mmol/L
Standard Deviation 1.181
|
-0.60 mmol/L
Standard Deviation 1.327
|
-0.45 mmol/L
Standard Deviation 1.249
|
|
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.32 mmol/L
Standard Deviation 1.917
|
-0.55 mmol/L
Standard Deviation 1.479
|
-0.42 mmol/L
Standard Deviation 1.740
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
1.19 mmol/L
Standard Deviation 2.372
|
0.97 mmol/L
Standard Deviation 2.518
|
1.09 mmol/L
Standard Deviation 2.440
|
|
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
0.77 mmol/L
Standard Deviation 2.418
|
0.28 mmol/L
Standard Deviation 2.744
|
0.55 mmol/L
Standard Deviation 2.574
|
|
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
0.90 mmol/L
Standard Deviation 2.240
|
0.63 mmol/L
Standard Deviation 2.874
|
0.78 mmol/L
Standard Deviation 2.522
|
|
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
0.78 mmol/L
Standard Deviation 2.374
|
0.57 mmol/L
Standard Deviation 2.304
|
0.69 mmol/L
Standard Deviation 2.337
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.03 mmol/L
Standard Deviation 0.067
|
-0.03 mmol/L
Standard Deviation 0.058
|
-0.03 mmol/L
Standard Deviation 0.063
|
|
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-0.03 mmol/L
Standard Deviation 0.064
|
-0.02 mmol/L
Standard Deviation 0.062
|
-0.02 mmol/L
Standard Deviation 0.063
|
|
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Week 39
|
-0.02 mmol/L
Standard Deviation 0.076
|
-0.01 mmol/L
Standard Deviation 0.073
|
-0.02 mmol/L
Standard Deviation 0.075
|
|
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.03 mmol/L
Standard Deviation 0.078
|
-0.01 mmol/L
Standard Deviation 0.057
|
-0.02 mmol/L
Standard Deviation 0.070
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=1 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=1 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=2 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-0.08 mL/sec/1.73m^2
|
0.00 mL/sec/1.73m^2
|
-0.04 mL/sec/1.73m^2
Standard Deviation 0.059
|
|
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
—
|
-0.17 mL/sec/1.73m^2
|
-0.17 mL/sec/1.73m^2
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
3.07 µmol/L
Standard Deviation 5.301
|
6.70 µmol/L
Standard Deviation 11.040
|
4.79 µmol/L
Standard Deviation 8.692
|
|
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
4.22 µmol/L
Standard Deviation 7.549
|
6.69 µmol/L
Standard Deviation 6.306
|
5.32 µmol/L
Standard Deviation 7.106
|
|
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
4.88 µmol/L
Standard Deviation 6.103
|
7.24 µmol/L
Standard Deviation 8.687
|
5.86 µmol/L
Standard Deviation 7.351
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
0.30 nmol/L
Standard Deviation 129.306
|
4.68 nmol/L
Standard Deviation 87.199
|
2.38 nmol/L
Standard Deviation 111.069
|
|
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-4.50 nmol/L
Standard Deviation 89.013
|
14.10 nmol/L
Standard Deviation 103.462
|
3.86 nmol/L
Standard Deviation 95.865
|
|
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-0.32 nmol/L
Standard Deviation 124.059
|
44.30 nmol/L
Standard Deviation 124.456
|
18.95 nmol/L
Standard Deviation 125.703
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Week 6
|
-229.58 pmol/L
Standard Deviation 1349.008
|
-206.30 pmol/L
Standard Deviation 2217.016
|
-218.53 pmol/L
Standard Deviation 1808.859
|
|
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Week 26
|
-147.38 pmol/L
Standard Deviation 845.662
|
-143.30 pmol/L
Standard Deviation 1033.488
|
-145.53 pmol/L
Standard Deviation 931.955
|
|
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Week 52
|
-268.44 pmol/L
Standard Deviation 1684.785
|
-212.84 pmol/L
Standard Deviation 1096.656
|
-244.98 pmol/L
Standard Deviation 1460.902
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
pH (Urinalysis): Change From Baseline to End of Study
Week 6
|
0.07 no units
Standard Deviation 0.601
|
0.19 no units
Standard Deviation 0.575
|
0.13 no units
Standard Deviation 0.590
|
|
pH (Urinalysis): Change From Baseline to End of Study
Week 26
|
0.20 no units
Standard Deviation 0.537
|
0.24 no units
Standard Deviation 0.560
|
0.22 no units
Standard Deviation 0.546
|
|
pH (Urinalysis): Change From Baseline to End of Study
Week 39
|
0.13 no units
Standard Deviation 0.566
|
0.31 no units
Standard Deviation 0.617
|
0.21 no units
Standard Deviation 0.594
|
|
pH (Urinalysis): Change From Baseline to End of Study
Week 52
|
0.18 no units
Standard Deviation 0.682
|
0.20 no units
Standard Deviation 0.537
|
0.19 no units
Standard Deviation 0.620
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6, 26, 39, and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Week 6
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.007
|
0.00 No units
Standard Deviation 0.008
|
|
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Week 26
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.009
|
|
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Week 39
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.009
|
|
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Week 52
|
0.00 No units
Standard Deviation 0.010
|
0.00 No units
Standard Deviation 0.009
|
0.00 No units
Standard Deviation 0.009
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=128 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=240 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 6- standing
|
-2.9 mmHg
Standard Deviation 18.32
|
-3.1 mmHg
Standard Deviation 25.89
|
-3.0 mmHg
Standard Deviation 22.19
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 1- orthostatic
|
-1.5 mmHg
Standard Deviation 12.00
|
3.5 mmHg
Standard Deviation 16.01
|
0.9 mmHg
Standard Deviation 14.22
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 6- orthostatic
|
-1.5 mmHg
Standard Deviation 11.85
|
2.6 mmHg
Standard Deviation 17.33
|
0.5 mmHg
Standard Deviation 14.83
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 26- orthostatic
|
-2.4 mmHg
Standard Deviation 16.25
|
-0.3 mmHg
Standard Deviation 14.38
|
-1.4 mmHg
Standard Deviation 15.38
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 52- orthostatic
|
-1.3 mmHg
Standard Deviation 14.59
|
0.7 mmHg
Standard Deviation 13.75
|
-0.4 mmHg
Standard Deviation 14.19
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 26- standing
|
-4.7 mmHg
Standard Deviation 19.23
|
-4.0 mmHg
Standard Deviation 21.01
|
-4.4 mmHg
Standard Deviation 20.00
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 1- standing
|
-2.3 mmHg
Standard Deviation 17.05
|
-1.3 mmHg
Standard Deviation 25.50
|
-1.9 mmHg
Standard Deviation 21.35
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 52- standing
|
-3.9 mmHg
Standard Deviation 19.81
|
-1.5 mmHg
Standard Deviation 20.91
|
-2.8 mmHg
Standard Deviation 20.26
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 2- supine
|
-1.0 mmHg
Standard Deviation 16.75
|
-4.5 mmHg
Standard Deviation 21.94
|
-2.7 mmHg
Standard Deviation 19.42
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 4- supine
|
-1.2 mmHg
Standard Deviation 16.67
|
-6.7 mmHg
Standard Deviation 22.99
|
-3.8 mmHg
Standard Deviation 20.05
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 13- supine
|
-4.0 mmHg
Standard Deviation 18.34
|
-1.8 mmHg
Standard Deviation 24.89
|
-3.2 mmHg
Standard Deviation 20.75
|
|
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 39- supine
|
-1.7 mmHg
Standard Deviation 19.12
|
-1.8 mmHg
Standard Deviation 22.08
|
-1.7 mmHg
Standard Deviation 20.47
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=128 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=240 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 1- orthostatic
|
-1.9 mmHg
Standard Deviation 10.61
|
-0.7 mmHg
Standard Deviation 13.27
|
-1.3 mmHg
Standard Deviation 11.92
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 6- orthostatic
|
0.0 mmHg
Standard Deviation 10.91
|
-0.6 mmHg
Standard Deviation 10.00
|
-0.3 mmHg
Standard Deviation 10.46
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 26- orthostatic
|
-1.7 mmHg
Standard Deviation 12.99
|
0.3 mmHg
Standard Deviation 10.16
|
-0.7 mmHg
Standard Deviation 11.75
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 52- orthostatic
|
-1.5 mmHg
Standard Deviation 10.44
|
0.8 mmHg
Standard Deviation 11.42
|
-0.4 mmHg
Standard Deviation 10.91
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 1- standing
|
-2.6 mmHg
Standard Deviation 12.00
|
-2.1 mmHg
Standard Deviation 13.87
|
-2.4 mmHg
Standard Deviation 12.88
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 6- standing
|
-0.8 mmHg
Standard Deviation 12.27
|
-2.2 mmHg
Standard Deviation 14.76
|
-1.5 mmHg
Standard Deviation 13.50
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 26- standing
|
-4.0 mmHg
Standard Deviation 12.20
|
-1.2 mmHg
Standard Deviation 14.67
|
-2.7 mmHg
Standard Deviation 13.42
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 52- standing
|
-1.7 mmHg
Standard Deviation 12.55
|
1.1 mmHg
Standard Deviation 12.01
|
-0.4 mmHg
Standard Deviation 12.34
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 2- supine
|
-1.1 mmHg
Standard Deviation 12.46
|
-1.3 mmHg
Standard Deviation 13.46
|
-1.2 mmHg
Standard Deviation 12.91
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 4- supine
|
-1.4 mmHg
Standard Deviation 12.06
|
-2.1 mmHg
Standard Deviation 12.80
|
-1.7 mmHg
Standard Deviation 12.38
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 13- supine
|
-2.6 mmHg
Standard Deviation 12.52
|
-0.5 mmHg
Standard Deviation 9.59
|
-1.8 mmHg
Standard Deviation 11.46
|
|
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Week 39- supine
|
0.2 mmHg
Standard Deviation 12.16
|
0.2 mmHg
Standard Deviation 12.77
|
0.2 mmHg
Standard Deviation 12.40
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=128 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=240 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 4- supine
|
-2.6 beats/minute
Standard Deviation 10.06
|
-3.3 beats/minute
Standard Deviation 12.60
|
-3.0 beats/minute
Standard Deviation 11.31
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 13- supine
|
1.1 beats/minute
Standard Deviation 11.72
|
-4.8 beats/minute
Standard Deviation 7.60
|
-1.1 beats/minute
Standard Deviation 10.68
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 39- supine
|
-3.7 beats/minute
Standard Deviation 11.76
|
-3.2 beats/minute
Standard Deviation 11.16
|
-3.4 beats/minute
Standard Deviation 11.45
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 1- orthostatic
|
-1.5 beats/minute
Standard Deviation 8.49
|
-1.8 beats/minute
Standard Deviation 10.49
|
-1.6 beats/minute
Standard Deviation 9.46
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 6- orthostatic
|
-0.5 beats/minute
Standard Deviation 10.86
|
0.2 beats/minute
Standard Deviation 10.16
|
-0.1 beats/minute
Standard Deviation 10.51
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 26- orthostatic
|
-0.9 beats/minute
Standard Deviation 8.90
|
0.3 beats/minute
Standard Deviation 9.32
|
-0.4 beats/minute
Standard Deviation 9.08
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 52- orthostatic
|
0.5 beats/minute
Standard Deviation 9.72
|
-0.5 beats/minute
Standard Deviation 8.55
|
0.0 beats/minute
Standard Deviation 9.19
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 1- standing
|
-5.1 beats/minute
Standard Deviation 11.43
|
-2.6 beats/minute
Standard Deviation 12.50
|
-3.9 beats/minute
Standard Deviation 11.98
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 6- standing
|
-3.1 beats/minute
Standard Deviation 12.45
|
-3.0 beats/minute
Standard Deviation 12.23
|
-3.1 beats/minute
Standard Deviation 12.31
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 26- standing
|
-2.9 beats/minute
Standard Deviation 12.29
|
-2.4 beats/minute
Standard Deviation 12.43
|
-2.7 beats/minute
Standard Deviation 12.31
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 52- standing
|
-3.8 beats/minute
Standard Deviation 12.88
|
-4.3 beats/minute
Standard Deviation 11.56
|
-4.0 beats/minute
Standard Deviation 12.27
|
|
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Week 2- supine
|
-3.3 beats/minute
Standard Deviation 10.05
|
-0.6 beats/minute
Standard Deviation 11.10
|
-2.0 beats/minute
Standard Deviation 10.62
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Day 1 (postdose)
|
2.1 beats/minute
Standard Deviation 9.51
|
2.2 beats/minute
Standard Deviation 9.76
|
2.1 beats/minute
Standard Deviation 9.61
|
|
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Week 6
|
-2.3 beats/minute
Standard Deviation 8.60
|
-2.2 beats/minute
Standard Deviation 10.28
|
-2.2 beats/minute
Standard Deviation 9.40
|
|
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Week 52
|
-3.7 beats/minute
Standard Deviation 9.51
|
-0.7 beats/minute
Standard Deviation 11.36
|
-2.3 beats/minute
Standard Deviation 10.44
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=130 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=107 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=237 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Day 1 (postdose)
|
0.4 milliseconds
Standard Deviation 14.08
|
-0.1 milliseconds
Standard Deviation 13.76
|
0.2 milliseconds
Standard Deviation 13.91
|
|
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Week 6
|
0.5 milliseconds
Standard Deviation 13.97
|
1.1 milliseconds
Standard Deviation 16.84
|
0.8 milliseconds
Standard Deviation 15.31
|
|
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Week 52
|
1.5 milliseconds
Standard Deviation 12.48
|
-5.8 milliseconds
Standard Deviation 20.54
|
-1.6 milliseconds
Standard Deviation 16.75
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Day 1 (postdose)
|
-2.3 milliseconds
Standard Deviation 7.32
|
-0.8 milliseconds
Standard Deviation 8.41
|
-1.6 milliseconds
Standard Deviation 7.87
|
|
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Week 6
|
-0.5 milliseconds
Standard Deviation 8.32
|
1.6 milliseconds
Standard Deviation 8.96
|
0.5 milliseconds
Standard Deviation 8.67
|
|
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Week 52
|
-0.2 milliseconds
Standard Deviation 6.85
|
0.9 milliseconds
Standard Deviation 7.29
|
0.3 milliseconds
Standard Deviation 7.04
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Day 1 (postdose)
|
-5.3 milliseconds
Standard Deviation 20.72
|
-4.2 milliseconds
Standard Deviation 23.99
|
-4.8 milliseconds
Standard Deviation 22.27
|
|
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Week 6
|
6.4 milliseconds
Standard Deviation 20.96
|
6.4 milliseconds
Standard Deviation 24.61
|
6.4 milliseconds
Standard Deviation 22.69
|
|
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Week 52
|
9.8 milliseconds
Standard Deviation 24.66
|
4.3 milliseconds
Standard Deviation 26.24
|
7.3 milliseconds
Standard Deviation 25.42
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Day 1 (postdose)
|
1.2 milliseconds
Standard Deviation 17.96
|
2.0 milliseconds
Standard Deviation 17.21
|
1.6 milliseconds
Standard Deviation 17.58
|
|
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Week 6
|
1.0 milliseconds
Standard Deviation 19.91
|
0.6 milliseconds
Standard Deviation 18.34
|
0.8 milliseconds
Standard Deviation 19.14
|
|
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Week 52
|
-0.1 milliseconds
Standard Deviation 20.84
|
2.1 milliseconds
Standard Deviation 18.33
|
0.9 milliseconds
Standard Deviation 19.72
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Day 1 (postdose)
|
-1.0 milliseconds
Standard Deviation 14.03
|
-0.2 milliseconds
Standard Deviation 15.75
|
-0.6 milliseconds
Standard Deviation 14.84
|
|
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Week 6
|
3.1 milliseconds
Standard Deviation 16.49
|
2.6 milliseconds
Standard Deviation 15.63
|
2.9 milliseconds
Standard Deviation 16.05
|
|
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Week 52
|
3.4 milliseconds
Standard Deviation 18.05
|
2.9 milliseconds
Standard Deviation 15.40
|
3.2 milliseconds
Standard Deviation 16.86
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (postdose), Weeks 6 and 52Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Day 1 (postdose)
|
-30.7 milliseconds
Standard Deviation 122.48
|
-28.3 milliseconds
Standard Deviation 113.02
|
-29.6 milliseconds
Standard Deviation 117.90
|
|
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Week 6
|
22.6 milliseconds
Standard Deviation 112.51
|
26.1 milliseconds
Standard Deviation 129.35
|
24.2 milliseconds
Standard Deviation 120.37
|
|
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Week 52
|
41.8 milliseconds
Standard Deviation 122.96
|
9.4 milliseconds
Standard Deviation 141.91
|
27.5 milliseconds
Standard Deviation 132.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=126 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=110 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=236 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 1
|
-2.04 hours
Standard Deviation 3.51
|
-1.84 hours
Standard Deviation 3.88
|
-1.95 hours
Standard Deviation 3.68
|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 6
|
-2.43 hours
Standard Deviation 3.66
|
-2.36 hours
Standard Deviation 3.56
|
-2.40 hours
Standard Deviation 3.61
|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 13
|
-2.50 hours
Standard Deviation 3.83
|
-2.34 hours
Standard Deviation 3.57
|
-2.43 hours
Standard Deviation 3.70
|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 26
|
-3.31 hours
Standard Deviation 3.36
|
-3.38 hours
Standard Deviation 3.15
|
-3.35 hours
Standard Deviation 3.25
|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 39
|
-3.25 hours
Standard Deviation 3.43
|
-3.52 hours
Standard Deviation 2.92
|
-3.37 hours
Standard Deviation 3.21
|
|
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Week 52
|
-3.43 hours
Standard Deviation 3.16
|
-3.59 hours
Standard Deviation 3.11
|
-3.51 hours
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=126 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=110 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=236 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 1
|
-0.00 hours
Standard Deviation 2.10
|
0.11 hours
Standard Deviation 1.64
|
0.05 hours
Standard Deviation 1.89
|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 6
|
-0.56 hours
Standard Deviation 1.95
|
-0.23 hours
Standard Deviation 1.05
|
-0.41 hours
Standard Deviation 1.60
|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 13
|
-0.60 hours
Standard Deviation 1.72
|
-0.38 hours
Standard Deviation 1.04
|
-0.50 hours
Standard Deviation 1.45
|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 26
|
-0.61 hours
Standard Deviation 1.95
|
-0.27 hours
Standard Deviation 1.73
|
-0.45 hours
Standard Deviation 1.85
|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 39
|
-0.49 hours
Standard Deviation 1.07
|
-0.17 hours
Standard Deviation 1.59
|
-0.35 hours
Standard Deviation 1.33
|
|
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Week 52
|
-0.64 hours
Standard Deviation 1.73
|
0.17 hours
Standard Deviation 2.53
|
-0.27 hours
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=126 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=110 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=236 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 1
|
2.04 hours
Standard Deviation 3.55
|
1.74 hours
Standard Deviation 4.04
|
1.90 hours
Standard Deviation 3.78
|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 6
|
2.99 hours
Standard Deviation 3.60
|
2.60 hours
Standard Deviation 3.58
|
2.81 hours
Standard Deviation 3.59
|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 13
|
3.10 hours
Standard Deviation 3.32
|
2.72 hours
Standard Deviation 3.68
|
2.93 hours
Standard Deviation 3.48
|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 26
|
3.92 hours
Standard Deviation 3.76
|
3.65 hours
Standard Deviation 3.31
|
3.79 hours
Standard Deviation 3.55
|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 39
|
3.74 hours
Standard Deviation 3.40
|
3.69 hours
Standard Deviation 3.32
|
3.71 hours
Standard Deviation 3.35
|
|
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Week 52
|
4.08 hours
Standard Deviation 3.28
|
3.43 hours
Standard Deviation 3.28
|
3.77 hours
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Day 2
|
-2.6 units on a scale
Standard Deviation 4.28
|
-1.8 units on a scale
Standard Deviation 3.61
|
-2.3 units on a scale
Standard Deviation 4.00
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 1
|
-2.6 units on a scale
Standard Deviation 5.84
|
-3.3 units on a scale
Standard Deviation 5.50
|
-2.9 units on a scale
Standard Deviation 5.68
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 2
|
-2.5 units on a scale
Standard Deviation 5.29
|
-2.1 units on a scale
Standard Deviation 5.10
|
-2.3 units on a scale
Standard Deviation 5.20
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 3
|
-2.3 units on a scale
Standard Deviation 5.65
|
-2.9 units on a scale
Standard Deviation 5.91
|
-2.6 units on a scale
Standard Deviation 5.77
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 4
|
-1.7 units on a scale
Standard Deviation 6.22
|
-3.0 units on a scale
Standard Deviation 5.42
|
-2.3 units on a scale
Standard Deviation 5.88
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 6
|
-1.1 units on a scale
Standard Deviation 7.00
|
-1.7 units on a scale
Standard Deviation 5.15
|
-1.4 units on a scale
Standard Deviation 6.21
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 13
|
-1.8 units on a scale
Standard Deviation 5.80
|
-1.7 units on a scale
Standard Deviation 5.59
|
-1.7 units on a scale
Standard Deviation 5.69
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 26
|
-1.1 units on a scale
Standard Deviation 5.01
|
-0.7 units on a scale
Standard Deviation 5.88
|
-0.9 units on a scale
Standard Deviation 5.42
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 39
|
-0.7 units on a scale
Standard Deviation 5.64
|
0.1 units on a scale
Standard Deviation 6.00
|
-0.4 units on a scale
Standard Deviation 5.80
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Week 52
|
-0.5 units on a scale
Standard Deviation 5.30
|
-1.3 units on a scale
Standard Deviation 6.22
|
-0.9 units on a scale
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Day 2
|
-2.8 units on a scale
Standard Deviation 4.55
|
-1.2 units on a scale
Standard Deviation 4.25
|
-2.1 units on a scale
Standard Deviation 4.47
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 1
|
-3.6 units on a scale
Standard Deviation 4.98
|
-3.9 units on a scale
Standard Deviation 5.85
|
-3.7 units on a scale
Standard Deviation 5.40
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 2
|
-3.3 units on a scale
Standard Deviation 6.06
|
-3.4 units on a scale
Standard Deviation 6.53
|
-3.3 units on a scale
Standard Deviation 6.26
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 3
|
-3.5 units on a scale
Standard Deviation 5.83
|
-3.9 units on a scale
Standard Deviation 6.63
|
-3.7 units on a scale
Standard Deviation 6.21
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 4
|
-2.6 units on a scale
Standard Deviation 5.50
|
-4.9 units on a scale
Standard Deviation 6.32
|
-3.7 units on a scale
Standard Deviation 5.98
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 6
|
-2.5 units on a scale
Standard Deviation 6.60
|
-4.2 units on a scale
Standard Deviation 6.09
|
-3.3 units on a scale
Standard Deviation 6.41
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 13
|
-3.2 units on a scale
Standard Deviation 6.44
|
-4.3 units on a scale
Standard Deviation 6.57
|
-3.7 units on a scale
Standard Deviation 6.50
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 26
|
-2.6 units on a scale
Standard Deviation 6.27
|
-3.9 units on a scale
Standard Deviation 7.05
|
-3.2 units on a scale
Standard Deviation 6.65
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 39
|
-2.6 units on a scale
Standard Deviation 6.32
|
-4.0 units on a scale
Standard Deviation 6.93
|
-3.2 units on a scale
Standard Deviation 6.61
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Week 52
|
-2.1 units on a scale
Standard Deviation 6.94
|
-4.5 units on a scale
Standard Deviation 7.07
|
-3.2 units on a scale
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Day 2
|
-0.6 units on a scale
Standard Deviation 8.45
|
-0.8 units on a scale
Standard Deviation 9.20
|
-0.7 units on a scale
Standard Deviation 8.78
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 1
|
2.0 units on a scale
Standard Deviation 11.55
|
3.8 units on a scale
Standard Deviation 11.00
|
2.8 units on a scale
Standard Deviation 11.31
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 2
|
4.1 units on a scale
Standard Deviation 13.02
|
1.4 units on a scale
Standard Deviation 10.93
|
2.9 units on a scale
Standard Deviation 12.18
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 3
|
3.9 units on a scale
Standard Deviation 11.98
|
2.2 units on a scale
Standard Deviation 12.07
|
3.1 units on a scale
Standard Deviation 12.02
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 4
|
2.7 units on a scale
Standard Deviation 12.84
|
0.0 units on a scale
Standard Deviation 10.97
|
1.5 units on a scale
Standard Deviation 12.05
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 6
|
2.4 units on a scale
Standard Deviation 13.74
|
-0.7 units on a scale
Standard Deviation 9.58
|
0.9 units on a scale
Standard Deviation 12.07
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 13
|
1.4 units on a scale
Standard Deviation 13.79
|
-1.6 units on a scale
Standard Deviation 11.82
|
0.1 units on a scale
Standard Deviation 13.01
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 26
|
1.4 units on a scale
Standard Deviation 12.71
|
0.1 units on a scale
Standard Deviation 11.61
|
0.8 units on a scale
Standard Deviation 12.19
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 39
|
1.9 units on a scale
Standard Deviation 12.70
|
2.3 units on a scale
Standard Deviation 13.26
|
2.1 units on a scale
Standard Deviation 12.89
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Week 52
|
1.8 units on a scale
Standard Deviation 12.53
|
1.7 units on a scale
Standard Deviation 13.02
|
1.7 units on a scale
Standard Deviation 12.69
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 52
|
-4.1 units on a scale
Standard Deviation 3.75
|
-3.8 units on a scale
Standard Deviation 4.71
|
-3.9 units on a scale
Standard Deviation 4.19
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Day 2
|
-1.8 units on a scale
Standard Deviation 3.57
|
-1.1 units on a scale
Standard Deviation 3.45
|
-1.5 units on a scale
Standard Deviation 3.52
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 1
|
-1.7 units on a scale
Standard Deviation 3.86
|
-1.7 units on a scale
Standard Deviation 4.10
|
-1.7 units on a scale
Standard Deviation 3.96
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 2
|
-2.5 units on a scale
Standard Deviation 3.58
|
-2.3 units on a scale
Standard Deviation 3.56
|
-2.4 units on a scale
Standard Deviation 3.57
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 3
|
-2.1 units on a scale
Standard Deviation 4.06
|
-2.3 units on a scale
Standard Deviation 3.74
|
-2.2 units on a scale
Standard Deviation 3.90
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 4
|
-3.0 units on a scale
Standard Deviation 3.69
|
-2.6 units on a scale
Standard Deviation 3.78
|
-2.8 units on a scale
Standard Deviation 3.73
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 6
|
-2.6 units on a scale
Standard Deviation 3.34
|
-2.8 units on a scale
Standard Deviation 3.90
|
-2.7 units on a scale
Standard Deviation 3.61
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 13
|
-3.7 units on a scale
Standard Deviation 3.47
|
-3.3 units on a scale
Standard Deviation 4.04
|
-3.5 units on a scale
Standard Deviation 3.74
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 26
|
-3.5 units on a scale
Standard Deviation 3.43
|
-3.5 units on a scale
Standard Deviation 4.12
|
-3.5 units on a scale
Standard Deviation 3.76
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Week 39
|
-3.5 units on a scale
Standard Deviation 4.06
|
-3.5 units on a scale
Standard Deviation 4.11
|
-3.5 units on a scale
Standard Deviation 4.07
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\] with the exception of Question 1 score ranging from 0 \[very often\] to 4 \[never\]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Week 6
|
-5.0 units on a scale
Standard Deviation 11.39
|
-7.3 units on a scale
Standard Deviation 8.81
|
-6.1 units on a scale
Standard Deviation 10.31
|
|
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Week 13
|
-6.9 units on a scale
Standard Deviation 10.76
|
-8.2 units on a scale
Standard Deviation 8.89
|
-7.5 units on a scale
Standard Deviation 9.94
|
|
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Week 26
|
-5.0 units on a scale
Standard Deviation 13.06
|
-8.4 units on a scale
Standard Deviation 8.07
|
-6.6 units on a scale
Standard Deviation 11.12
|
|
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Week 39
|
-7.0 units on a scale
Standard Deviation 11.19
|
-7.2 units on a scale
Standard Deviation 9.21
|
-7.1 units on a scale
Standard Deviation 10.32
|
|
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Week 52
|
-6.5 units on a scale
Standard Deviation 12.34
|
-8.7 units on a scale
Standard Deviation 8.19
|
-7.5 units on a scale
Standard Deviation 10.75
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=131 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=112 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=243 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Week 6
|
-7.0 units on a scale
Standard Deviation 14.53
|
-8.4 units on a scale
Standard Deviation 10.53
|
-7.6 units on a scale
Standard Deviation 12.81
|
|
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Week 13
|
-8.3 units on a scale
Standard Deviation 15.33
|
-8.2 units on a scale
Standard Deviation 11.18
|
-8.3 units on a scale
Standard Deviation 13.57
|
|
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Week 26
|
-7.4 units on a scale
Standard Deviation 13.00
|
-7.1 units on a scale
Standard Deviation 12.27
|
-7.3 units on a scale
Standard Deviation 12.62
|
|
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Week 39
|
-7.8 units on a scale
Standard Deviation 13.81
|
-7.5 units on a scale
Standard Deviation 13.58
|
-7.7 units on a scale
Standard Deviation 13.66
|
|
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Week 52
|
-7.2 units on a scale
Standard Deviation 14.65
|
-7.2 units on a scale
Standard Deviation 12.35
|
-7.2 units on a scale
Standard Deviation 13.65
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 13, 26, 39, and 52Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.
Outcome measures
| Measure |
ABBV-951 Low Dose Subgroup
n=125 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=104 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=229 Participants
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
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|---|---|---|---|
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The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Week 6
|
0.060 units on a scale
Standard Deviation 0.1921
|
0.113 units on a scale
Standard Deviation 0.1780
|
0.085 units on a scale
Standard Deviation 0.1870
|
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The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Week 13
|
0.064 units on a scale
Standard Deviation 0.2153
|
0.122 units on a scale
Standard Deviation 0.1984
|
0.090 units on a scale
Standard Deviation 0.2092
|
|
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Week 26
|
0.074 units on a scale
Standard Deviation 0.1771
|
0.122 units on a scale
Standard Deviation 0.1803
|
0.096 units on a scale
Standard Deviation 0.1795
|
|
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Week 39
|
0.075 units on a scale
Standard Deviation 0.1842
|
0.129 units on a scale
Standard Deviation 0.1995
|
0.097 units on a scale
Standard Deviation 0.1916
|
|
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Week 52
|
0.076 units on a scale
Standard Deviation 0.2062
|
0.126 units on a scale
Standard Deviation 0.2213
|
0.097 units on a scale
Standard Deviation 0.2134
|
Adverse Events
ABBV-951 Low Dose Subgroup
ABBV-951 High Dose Subgroup
ABBV-951 All Participants
Serious adverse events
| Measure |
ABBV-951 Low Dose Subgroup
n=131 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
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|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Eye disorders
PERIORBITAL PAIN
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Eye disorders
PERIORBITAL SWELLING
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
ASTHENIA
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
CHEST PAIN
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
HYPOTHERMIA
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE HAEMATOMA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE INJURY
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
COVID-19
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE ABSCESS
|
3.8%
5/131 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.7%
3/113 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.3%
8/244 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE CELLULITIS
|
3.1%
4/131 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.1%
10/244 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE INFECTION
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
PAROTID ABSCESS
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
PNEUMONIA
|
1.5%
2/131 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.2%
3/244 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
SEPSIS
|
2.3%
3/131 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.2%
3/244 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.5%
2/131 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.8%
2/113 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.6%
4/244 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
FALL
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS REACTIVE
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Musculoskeletal and connective tissue disorders
SACROILIAC JOINT DYSFUNCTION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
CEREBRAL MASS EFFECT
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
DIZZINESS
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.8%
2/113 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
HEMIANAESTHESIA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
HEMIPARESIS
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
LUMBOSACRAL RADICULOPATHY
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
ON AND OFF PHENOMENON
|
0.76%
1/131 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
3.8%
5/131 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.5%
6/244 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
PARKINSONISM
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
PSYCHOGENIC SEIZURE
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
DELIRIUM
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
DELUSION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.82%
2/244 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
DELUSIONAL DISORDER, UNSPECIFIED TYPE
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
DOPAMINE DYSREGULATION SYNDROME
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
HALLUCINATION
|
4.6%
6/131 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.9%
7/244 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
3.1%
4/131 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
1.8%
2/113 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.5%
6/244 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/131 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.00%
0/113 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.41%
1/244 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
Other adverse events
| Measure |
ABBV-951 Low Dose Subgroup
n=131 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
|
ABBV-951 High Dose Subgroup
n=113 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
|
ABBV-951 All Participants
n=244 participants at risk
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.
|
|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
6.1%
8/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
10.6%
12/113 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.2%
20/244 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Gastrointestinal disorders
NAUSEA
|
6.1%
8/131 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
9.7%
11/113 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.8%
19/244 • Number of events 24 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE BRUISING
|
7.6%
10/131 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.1%
8/113 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.4%
18/244 • Number of events 30 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE ERYTHEMA
|
48.9%
64/131 • Number of events 175 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
55.8%
63/113 • Number of events 168 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
52.0%
127/244 • Number of events 343 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
6.1%
8/131 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
10.6%
12/113 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.2%
20/244 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE HAEMATOMA
|
7.6%
10/131 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
6.2%
7/113 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.0%
17/244 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE INFLAMMATION
|
2.3%
3/131 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.7%
9/244 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE NODULE
|
27.5%
36/131 • Number of events 65 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
30.1%
34/113 • Number of events 58 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
28.7%
70/244 • Number of events 123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE OEDEMA
|
14.5%
19/131 • Number of events 78 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
24.8%
28/113 • Number of events 45 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
19.3%
47/244 • Number of events 123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE PAIN
|
13.7%
18/131 • Number of events 41 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
17.7%
20/113 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
15.6%
38/244 • Number of events 68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE PAPULE
|
5.3%
7/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
9.7%
11/113 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.4%
18/244 • Number of events 26 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INFUSION SITE REACTION
|
9.9%
13/131 • Number of events 26 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
15.0%
17/113 • Number of events 36 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
12.3%
30/244 • Number of events 62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
4.6%
6/131 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.1%
8/113 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.7%
14/244 • Number of events 36 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INJECTION SITE NODULE
|
2.3%
3/131 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.7%
9/244 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
General disorders
INJECTION SITE PAIN
|
1.5%
2/131 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.3%
8/244 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE ABSCESS
|
6.9%
9/131 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.8%
10/113 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.8%
19/244 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE CELLULITIS
|
19.1%
25/131 • Number of events 33 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
18.6%
21/113 • Number of events 31 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
18.9%
46/244 • Number of events 64 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
INFUSION SITE INFECTION
|
5.3%
7/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.8%
10/113 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.0%
17/244 • Number of events 24 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.6%
6/131 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.0%
9/113 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
6.1%
15/244 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.5%
2/131 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.3%
8/244 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
FALL
|
12.2%
16/131 • Number of events 42 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
20.4%
23/113 • Number of events 35 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
16.0%
39/244 • Number of events 77 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.76%
1/131 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.9%
7/244 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Investigations
VITAMIN B6 DECREASED
|
3.8%
5/131 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.5%
11/244 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Investigations
WEIGHT DECREASED
|
7.6%
10/131 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
12.4%
14/113 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
9.8%
24/244 • Number of events 24 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.1%
8/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.4%
5/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
13/244 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
DIZZINESS
|
10.7%
14/131 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.8%
10/113 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
9.8%
24/244 • Number of events 28 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
DYSKINESIA
|
9.2%
12/131 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.4%
18/244 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
HEADACHE
|
5.3%
7/131 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
6.2%
7/113 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.7%
14/244 • Number of events 17 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
5.3%
7/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.5%
4/113 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.5%
11/244 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Nervous system disorders
SOMNOLENCE
|
6.9%
9/131 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
2.7%
3/113 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.9%
12/244 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
ANXIETY
|
7.6%
10/131 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
15.9%
18/113 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
11.5%
28/244 • Number of events 34 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
DELUSION
|
5.3%
7/131 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
0.88%
1/113 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
3.3%
8/244 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
HALLUCINATION
|
10.7%
14/131 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
18.6%
21/113 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
14.3%
35/244 • Number of events 49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
7.6%
10/131 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.4%
5/113 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
6.1%
15/244 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Psychiatric disorders
INSOMNIA
|
6.9%
9/131 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
8.0%
9/113 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
7.4%
18/244 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
4.6%
6/131 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
5.3%
6/113 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.
|
4.9%
12/244 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants 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