Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease (NCT NCT02880956)
NCT ID: NCT02880956
Last Updated: 2022-08-26
Results Overview
The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
453 participants
Primary outcome timeframe
Baseline, Week 24, Week 48, Week 72, Week 96
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
ABBV-8E12 300 mg
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
116
|
108
|
116
|
113
|
|
Overall Study
COMPLETED
|
99
|
93
|
105
|
95
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
11
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
ABBV-8E12 300 mg
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
6
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
COVID-19 Logistical Restrictions
|
1
|
2
|
0
|
0
|
|
Overall Study
Other, Not Specified
|
4
|
2
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Age, Customized
>= 65 years
|
101 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
368 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
437 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
None
|
112 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
436 Participants
n=21 Participants
|
|
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
|
3.0 score on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.0 score on a scale
STANDARD_DEVIATION 1.12 • n=7 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 1.24 • n=5 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 1.14 • n=4 Participants
|
3.0 score on a scale
STANDARD_DEVIATION 1.18 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in CDR-SB Score
Change to Week 24
|
0.66 score on a scale
Standard Error 0.129
|
0.44 score on a scale
Standard Error 0.125
|
0.63 score on a scale
Standard Error 0.130
|
0.60 score on a scale
Standard Error 0.125
|
|
Change From Baseline Over Time in CDR-SB Score
Change to Week 48
|
1.15 score on a scale
Standard Error 0.161
|
1.05 score on a scale
Standard Error 0.154
|
0.99 score on a scale
Standard Error 0.161
|
1.06 score on a scale
Standard Error 0.155
|
|
Change From Baseline Over Time in CDR-SB Score
Change to Week 72
|
1.88 score on a scale
Standard Error 0.220
|
1.85 score on a scale
Standard Error 0.212
|
1.81 score on a scale
Standard Error 0.219
|
1.90 score on a scale
Standard Error 0.213
|
|
Change From Baseline Over Time in CDR-SB Score
Change to Week 96
|
2.47 score on a scale
Standard Error 0.277
|
2.48 score on a scale
Standard Error 0.267
|
2.70 score on a scale
Standard Error 0.279
|
2.54 score on a scale
Standard Error 0.271
|
PRIMARY outcome
Timeframe: From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)Population: Safety Dataset: participants who received at least 1 dose of study drug.
A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
94 participants
|
108 participants
|
104 participants
|
108 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Severe TEAE
|
13 participants
|
14 participants
|
11 participants
|
12 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE With a Reasonable Possibility to Study Drug
|
32 participants
|
31 participants
|
33 participants
|
28 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Discontinuation of Study Drug
|
6 participants
|
6 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Fatal TEAE
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All Deaths
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
SAE
|
19 participants
|
22 participants
|
17 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
284 µg/mL
Geometric Coefficient of Variation 21
|
528 µg/mL
Geometric Coefficient of Variation 27
|
—
|
108 µg/mL
Geometric Coefficient of Variation 28
|
|
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
426 µg/mL
Geometric Coefficient of Variation 20
|
806 µg/mL
Geometric Coefficient of Variation 37
|
—
|
168 µg/mL
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
2.5 hours
Interval 1.3 to 4.2
|
2.7 hours
Interval 1.7 to 3.6
|
—
|
3 hours
Interval 1.8 to 4.2
|
|
Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
2.5 hours
Interval 1.7 to 4.3
|
2.3 hours
Interval 1.7 to 3.6
|
—
|
2.4 hours
Interval 1.1 to 4.1
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
75.1 µg/mL
Geometric Coefficient of Variation 33
|
163 µg/mL
Geometric Coefficient of Variation 26
|
—
|
28.6 µg/mL
Geometric Coefficient of Variation 22
|
|
Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
182 µg/mL
Geometric Coefficient of Variation 29
|
320 µg/mL
Geometric Coefficient of Variation 36
|
—
|
56.4 µg/mL
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
Harmonic mean is presented in the data table.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
19.4 days
Standard Deviation 8.87
|
33.2 days
Standard Deviation 10.5
|
—
|
22.0 days
Standard Deviation 17.2
|
|
Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
24.0 days
Standard Deviation 16.6
|
37.5 days
Standard Deviation 13.5
|
—
|
19.6 days
Standard Deviation 6.09
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
* The AUC0-28 for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2). * The AUC0-28 for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
6090 µg.day/mL
Geometric Coefficient of Variation 37
|
14800 µg.day/mL
Geometric Coefficient of Variation 25
|
—
|
2520 µg.day/mL
Geometric Coefficient of Variation 28
|
|
Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
13100 µg.day/mL
Geometric Coefficient of Variation 36
|
30200 µg.day/mL
Geometric Coefficient of Variation 36
|
—
|
4230 µg.day/mL
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
0.284 µg/mL/mg
Geometric Coefficient of Variation 21
|
0.264 µg/mL/mg
Geometric Coefficient of Variation 27
|
—
|
0.359 µg/mL/mg
Geometric Coefficient of Variation 28
|
|
Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
0.426 µg/mL/mg
Geometric Coefficient of Variation 20
|
0.403 µg/mL/mg
Geometric Coefficient of Variation 37
|
—
|
0.561 µg/mL/mg
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.Population: Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point.
* The AUC0-28/dose for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2). * The AUC0-28/dose for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=17 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=9 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=12 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
First Dosing Interval
|
6.09 µg.day/mL/mg
Geometric Coefficient of Variation 37
|
7.41 µg.day/mL/mg
Geometric Coefficient of Variation 25
|
—
|
8.40 µg.day/mL/mg
Geometric Coefficient of Variation 28
|
|
AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Fourth Dosing Interval
|
13.1 µg.day/mL/mg
Geometric Coefficient of Variation 36
|
15.1 µg.day/mL/mg
Geometric Coefficient of Variation 36
|
—
|
14.1 µg.day/mL/mg
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
Change at Week 24
|
1.42 score on a scale
Standard Error 0.498
|
0.56 score on a scale
Standard Error 0.480
|
1.86 score on a scale
Standard Error 0.503
|
1.82 score on a scale
Standard Error 0.492
|
|
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
Change at Week 48
|
3.51 score on a scale
Standard Error 0.642
|
3.42 score on a scale
Standard Error 0.605
|
4.03 score on a scale
Standard Error 0.647
|
4.50 score on a scale
Standard Error 0.621
|
|
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
Change at Week 72
|
4.78 score on a scale
Standard Error 0.730
|
5.00 score on a scale
Standard Error 0.706
|
6.37 score on a scale
Standard Error 0.738
|
5.26 score on a scale
Standard Error 0.718
|
|
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
Change at Week 96
|
7.99 score on a scale
Standard Error 0.891
|
7.84 score on a scale
Standard Error 0.872
|
9.46 score on a scale
Standard Error 0.935
|
8.43 score on a scale
Standard Error 0.898
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
Change at Week 72
|
0.11 score on a scale
Standard Error 0.066
|
0.14 score on a scale
Standard Error 0.064
|
0.31 score on a scale
Standard Error 0.066
|
0.17 score on a scale
Standard Error 0.064
|
|
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
Change at Week 96
|
0.26 score on a scale
Standard Error 0.083
|
0.19 score on a scale
Standard Error 0.080
|
0.29 score on a scale
Standard Error 0.085
|
0.30 score on a scale
Standard Error 0.083
|
|
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
Change at Week 24
|
0.03 score on a scale
Standard Error 0.038
|
0.04 score on a scale
Standard Error 0.037
|
0.08 score on a scale
Standard Error 0.039
|
0.01 score on a scale
Standard Error 0.038
|
|
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
Change at Week 48
|
0.09 score on a scale
Standard Error 0.046
|
0.07 score on a scale
Standard Error 0.044
|
0.12 score on a scale
Standard Error 0.046
|
0.03 score on a scale
Standard Error 0.044
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
Change at Week 96
|
0.25 score on a scale
Standard Error 0.089
|
0.026 score on a scale
Standard Error 0.086
|
0.33 score on a scale
Standard Error 0.092
|
0.41 score on a scale
Standard Error 0.089
|
|
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
Change at Week 24
|
0.05 score on a scale
Standard Error 0.058
|
-0.02 score on a scale
Standard Error 0.056
|
0.09 score on a scale
Standard Error 0.059
|
0.11 score on a scale
Standard Error 0.057
|
|
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
Change at Week 48
|
0.23 score on a scale
Standard Error 0.077
|
0.17 score on a scale
Standard Error 0.072
|
0.20 score on a scale
Standard Error 0.077
|
0.07 score on a scale
Standard Error 0.073
|
|
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
Change at Week 72
|
0.22 score on a scale
Standard Error 0.072
|
0.16 score on a scale
Standard Error 0.070
|
0.16 score on a scale
Standard Error 0.071
|
0.25 score on a scale
Standard Error 0.069
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Commands Score
Change at Week 24
|
0.10 score on a scale
Standard Error 0.067
|
0.09 score on a scale
Standard Error 0.065
|
0.09 score on a scale
Standard Error 0.068
|
0.09 score on a scale
Standard Error 0.066
|
|
Change From Baseline Over Time in ADAS-Cog-14 Commands Score
Change at Week 48
|
0.12 score on a scale
Standard Error 0.076
|
0.09 score on a scale
Standard Error 0.071
|
0.22 score on a scale
Standard Error 0.075
|
0.17 score on a scale
Standard Error 0.072
|
|
Change From Baseline Over Time in ADAS-Cog-14 Commands Score
Change at Week 72
|
0.11 score on a scale
Standard Error 0.081
|
0.36 score on a scale
Standard Error 0.079
|
0.21 score on a scale
Standard Error 0.080
|
0.09 score on a scale
Standard Error 0.078
|
|
Change From Baseline Over Time in ADAS-Cog-14 Commands Score
Change at Week 96
|
0.36 score on a scale
Standard Error 0.103
|
0.40 score on a scale
Standard Error 0.100
|
0.40 score on a scale
Standard Error 0.106
|
0.30 score on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=115 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
Change at Week 24
|
0.17 score on a scale
Standard Error 0.135
|
-0.04 score on a scale
Standard Error 0.131
|
-0.09 score on a scale
Standard Error 0.137
|
0.11 score on a scale
Standard Error 0.133
|
|
Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
Change at Week 72
|
0.61 score on a scale
Standard Error 0.136
|
0.52 score on a scale
Standard Error 0.133
|
0.67 score on a scale
Standard Error 0.135
|
0.39 score on a scale
Standard Error 0.132
|
|
Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
Change at Week 96
|
0.80 score on a scale
Standard Error 0.135
|
0.60 score on a scale
Standard Error 0.131
|
0.66 score on a scale
Standard Error 0.138
|
0.86 score on a scale
Standard Error 0.135
|
|
Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
Change at Week 48
|
0.30 score on a scale
Standard Error 0.138
|
0.32 score on a scale
Standard Error 0.131
|
0.27 score on a scale
Standard Error 0.138
|
0.41 score on a scale
Standard Error 0.133
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
Change at Week 24
|
0.13 score on a scale
Standard Error 0.058
|
0.02 score on a scale
Standard Error 0.056
|
0.18 score on a scale
Standard Error 0.059
|
0.05 score on a scale
Standard Error 0.057
|
|
Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
Change at Week 48
|
0.12 score on a scale
Standard Error 0.078
|
0.09 score on a scale
Standard Error 0.073
|
0.16 score on a scale
Standard Error 0.078
|
0.21 score on a scale
Standard Error 0.075
|
|
Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
Change at Week 72
|
0.25 score on a scale
Standard Error 0.086
|
0.21 score on a scale
Standard Error 0.083
|
0.35 score on a scale
Standard Error 0.085
|
0.18 score on a scale
Standard Error 0.083
|
|
Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
Change at Week 96
|
0.26 score on a scale
Standard Error 0.112
|
0.41 score on a scale
Standard Error 0.108
|
0.42 score on a scale
Standard Error 0.114
|
0.35 score on a scale
Standard Error 0.111
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=107 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=112 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=114 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
Change at Week 72
|
0.14 score on a scale
Standard Error 0.166
|
0.04 score on a scale
Standard Error 0.162
|
0.40 score on a scale
Standard Error 0.167
|
0.32 score on a scale
Standard Error 0.160
|
|
Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
Change at Week 96
|
0.29 score on a scale
Standard Error 0.181
|
0.60 score on a scale
Standard Error 0.179
|
0.52 score on a scale
Standard Error 0.190
|
0.52 score on a scale
Standard Error 0.184
|
|
Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
Change at Week 24
|
-0.04 score on a scale
Standard Error 0.132
|
-0.20 score on a scale
Standard Error 0.129
|
0.17 score on a scale
Standard Error 0.134
|
0.15 score on a scale
Standard Error 0.130
|
|
Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
Change at Week 48
|
0.07 score on a scale
Standard Error 0.154
|
0.21 score on a scale
Standard Error 0.145
|
0.28 score on a scale
Standard Error 0.155
|
0.37 score on a scale
Standard Error 0.147
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=115 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=112 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=113 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
Change at Week 24
|
0.33 score on a scale
Standard Error 0.100
|
0.35 score on a scale
Standard Error 0.097
|
0.32 score on a scale
Standard Error 0.102
|
0.33 score on a scale
Standard Error 0.099
|
|
Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
Change at Week 48
|
0.42 score on a scale
Standard Error 0.118
|
0.42 score on a scale
Standard Error 0.112
|
0.22 score on a scale
Standard Error 0.118
|
0.43 score on a scale
Standard Error 0.114
|
|
Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
Change at Week 72
|
0.68 score on a scale
Standard Error 0.117
|
0.44 score on a scale
Standard Error 0.115
|
0.68 score on a scale
Standard Error 0.118
|
0.75 score on a scale
Standard Error 0.115
|
|
Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
Change at Week 96
|
0.84 score on a scale
Standard Error 0.137
|
0.74 score on a scale
Standard Error 0.133
|
0.77 score on a scale
Standard Error 0.143
|
0.87 score on a scale
Standard Error 0.138
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=114 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Naming Score
Change at Week 24
|
0.08 score on a scale
Standard Error 0.049
|
-0.03 score on a scale
Standard Error 0.047
|
0.05 score on a scale
Standard Error 0.050
|
0.02 score on a scale
Standard Error 0.048
|
|
Change From Baseline Over Time in ADAS-Cog-14 Naming Score
Change at Week 48
|
0.09 score on a scale
Standard Error 0.051
|
0.08 score on a scale
Standard Error 0.048
|
0.03 score on a scale
Standard Error 0.050
|
0.11 score on a scale
Standard Error 0.049
|
|
Change From Baseline Over Time in ADAS-Cog-14 Naming Score
Change at Week 72
|
0.14 score on a scale
Standard Error 0.065
|
0.08 score on a scale
Standard Error 0.063
|
0.07 score on a scale
Standard Error 0.064
|
0.21 score on a scale
Standard Error 0.063
|
|
Change From Baseline Over Time in ADAS-Cog-14 Naming Score
Change at Week 96
|
0.34 score on a scale
Standard Error 0.086
|
0.28 score on a scale
Standard Error 0.082
|
0.20 score on a scale
Standard Error 0.087
|
0.34 score on a scale
Standard Error 0.085
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
Change at Week 24
|
0.42 score on a scale
Standard Error 0.130
|
0.08 score on a scale
Standard Error 0.125
|
0.49 score on a scale
Standard Error 0.132
|
0.08 score on a scale
Standard Error 0.127
|
|
Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
Change at Week 48
|
0.77 score on a scale
Standard Error 0.154
|
0.45 score on a scale
Standard Error 0.145
|
0.61 score on a scale
Standard Error 0.153
|
0.63 score on a scale
Standard Error 0.147
|
|
Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
Change at Week 72
|
0.84 score on a scale
Standard Error 0.172
|
1.02 score on a scale
Standard Error 0.167
|
1.05 score on a scale
Standard Error 0.171
|
1.01 score on a scale
Standard Error 0.166
|
|
Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
Change at Week 96
|
1.46 score on a scale
Standard Error 0.197
|
1.28 score on a scale
Standard Error 0.191
|
2.00 score on a scale
Standard Error 0.202
|
1.26 score on a scale
Standard Error 0.196
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
Change at Week 24
|
0.03 score on a scale
Standard Error 0.100
|
0.16 score on a scale
Standard Error 0.097
|
0.11 score on a scale
Standard Error 0.101
|
0.16 score on a scale
Standard Error 0.098
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
Change at Week 48
|
0.32 score on a scale
Standard Error 0.105
|
0.41 score on a scale
Standard Error 0.100
|
0.38 score on a scale
Standard Error 0.105
|
0.39 score on a scale
Standard Error 0.101
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
Change at Week 72
|
0.64 score on a scale
Standard Error 0.117
|
0.60 score on a scale
Standard Error 0.114
|
0.70 score on a scale
Standard Error 0.116
|
0.58 score on a scale
Standard Error 0.113
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
Change at Week 96
|
0.97 score on a scale
Standard Error 0.132
|
0.89 score on a scale
Standard Error 0.127
|
0.91 score on a scale
Standard Error 0.135
|
1.04 score on a scale
Standard Error 0.131
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
Change at Week 24
|
0.03 score on a scale
Standard Error 0.051
|
0.15 score on a scale
Standard Error 0.049
|
-0.02 score on a scale
Standard Error 0.052
|
0.03 score on a scale
Standard Error 0.050
|
|
Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
Change at Week 48
|
0.10 score on a scale
Standard Error 0.074
|
0.19 score on a scale
Standard Error 0.070
|
0.06 score on a scale
Standard Error 0.074
|
0.27 score on a scale
Standard Error 0.071
|
|
Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
Change at Week 72
|
0.19 score on a scale
Standard Error 0.094
|
0.29 score on a scale
Standard Error 0.091
|
0.26 score on a scale
Standard Error 0.093
|
0.24 score on a scale
Standard Error 0.091
|
|
Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
Change at Week 96
|
0.45 score on a scale
Standard Error 0.113
|
0.27 score on a scale
Standard Error 0.111
|
0.46 score on a scale
Standard Error 0.117
|
0.40 score on a scale
Standard Error 0.112
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
Change at Week 24
|
0.08 score on a scale
Standard Error 0.046
|
0.06 score on a scale
Standard Error 0.045
|
0.11 score on a scale
Standard Error 0.047
|
0.07 score on a scale
Standard Error 0.045
|
|
Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
Change at Week 48
|
0.04 score on a scale
Standard Error 0.054
|
0.03 score on a scale
Standard Error 0.051
|
0.11 score on a scale
Standard Error 0.053
|
0.14 score on a scale
Standard Error 0.051
|
|
Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
Change at Week 72
|
0.11 score on a scale
Standard Error 0.069
|
0.19 score on a scale
Standard Error 0.066
|
0.24 score on a scale
Standard Error 0.068
|
0.23 score on a scale
Standard Error 0.066
|
|
Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
Change at Week 96
|
0.23 score on a scale
Standard Error 0.090
|
0.25 score on a scale
Standard Error 0.087
|
0.43 score on a scale
Standard Error 0.092
|
0.29 score on a scale
Standard Error 0.089
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
Change at Week 24
|
0.14 score on a scale
Standard Error 0.073
|
0.11 score on a scale
Standard Error 0.070
|
0.23 score on a scale
Standard Error 0.074
|
0.21 score on a scale
Standard Error 0.071
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
Change at Week 48
|
0.19 score on a scale
Standard Error 0.081
|
0.21 score on a scale
Standard Error 0.077
|
0.31 score on a scale
Standard Error 0.081
|
0.25 score on a scale
Standard Error 0.077
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
Change at Week 72
|
0.28 score on a scale
Standard Error 0.096
|
0.44 score on a scale
Standard Error 0.094
|
0.42 score on a scale
Standard Error 0.096
|
0.47 score on a scale
Standard Error 0.093
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
Change at Week 96
|
0.35 score on a scale
Standard Error 0.119
|
0.47 score on a scale
Standard Error 0.114
|
0.60 score on a scale
Standard Error 0.121
|
0.58 score on a scale
Standard Error 0.117
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
Change at Week 72
|
1.05 score on a scale
Standard Error 0.255
|
0.78 score on a scale
Standard Error 0.249
|
0.88 score on a scale
Standard Error 0.252
|
0.65 score on a scale
Standard Error 0.245
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
Change at Week 96
|
1.97 score on a scale
Standard Error 0.287
|
1.53 score on a scale
Standard Error 0.283
|
2.09 score on a scale
Standard Error 0.301
|
1.98 score on a scale
Standard Error 0.287
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
Change at Week 24
|
0.25 score on a scale
Standard Error 0.253
|
-0.20 score on a scale
Standard Error 0.245
|
-0.02 score on a scale
Standard Error 0.257
|
0.53 score on a scale
Standard Error 0.248
|
|
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
Change at Week 48
|
0.92 score on a scale
Standard Error 0.270
|
0.73 score on a scale
Standard Error 0.254
|
0.80 score on a scale
Standard Error 0.268
|
1.35 score on a scale
Standard Error 0.257
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). The FAQ score ranges from 0 - 30 and consists of 10 items (each scored from 0 - 3), which measure a specific iADL in the past 4-weeks: \[1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; and 10) traveling out of the neighborhood\]. Performance in each category is rated from 0 - 3 as follows: 0 - normal; 1 - has difficulty, but does by self; 2 - requires assistance; or 3 - dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
Change at Week 24
|
1.84 score on a scale
Standard Error 0.435
|
1.19 score on a scale
Standard Error 0.423
|
2.06 score on a scale
Standard Error 0.439
|
1.63 score on a scale
Standard Error 0.422
|
|
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
Change at Week 48
|
3.53 score on a scale
Standard Error 0.498
|
2.83 score on a scale
Standard Error 0.477
|
3.58 score on a scale
Standard Error 0.496
|
3.37 score on a scale
Standard Error 0.480
|
|
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
Change at Week 72
|
5.09 score on a scale
Standard Error 0.588
|
4.57 score on a scale
Standard Error 0.568
|
6.31 score on a scale
Standard Error 0.586
|
5.62 score on a scale
Standard Error 0.571
|
|
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
Change at Week 96
|
7.11 score on a scale
Standard Error 0.663
|
5.80 score on a scale
Standard Error 0.638
|
7.94 score on a scale
Standard Error 0.667
|
6.14 score on a scale
Standard Error 0.650
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score
Change at Week 96
|
5.28 score on a scale
Standard Error 0.087
|
5.22 score on a scale
Standard Error 0.083
|
5.34 score on a scale
Standard Error 0.088
|
5.29 score on a scale
Standard Error 0.087
|
|
Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score
Change at Week 48
|
4.86 score on a scale
Standard Error 0.080
|
4.80 score on a scale
Standard Error 0.076
|
4.87 score on a scale
Standard Error 0.079
|
4.91 score on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score
Change at Week 48
|
4.81 score on a scale
Standard Error 0.081
|
4.83 score on a scale
Standard Error 0.077
|
4.92 score on a scale
Standard Error 0.081
|
4.85 score on a scale
Standard Error 0.080
|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score
Change at Week 96
|
5.29 score on a scale
Standard Error 0.092
|
5.22 score on a scale
Standard Error 0.088
|
5.34 score on a scale
Standard Error 0.093
|
5.30 score on a scale
Standard Error 0.092
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score
Change at Week 48
|
4.31 score on a scale
Standard Error 0.062
|
4.28 score on a scale
Standard Error 0.059
|
4.33 score on a scale
Standard Error 0.062
|
4.30 score on a scale
Standard Error 0.061
|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score
Change at Week 96
|
4.49 score on a scale
Standard Error 0.078
|
4.57 score on a scale
Standard Error 0.076
|
4.55 score on a scale
Standard Error 0.080
|
4.61 score on a scale
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score
Change at Week 48
|
4.58 score on a scale
Standard Error 0.072
|
4.46 score on a scale
Standard Error 0.068
|
4.59 score on a scale
Standard Error 0.072
|
4.59 score on a scale
Standard Error 0.071
|
|
Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score
Change at Week 96
|
4.95 score on a scale
Standard Error 0.088
|
4.98 score on a scale
Standard Error 0.085
|
5.03 score on a scale
Standard Error 0.090
|
4.97 score on a scale
Standard Error 0.088
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=114 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=112 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score
Change to Week 48
|
-6.04 score on a scale
Standard Error 1.567
|
-4.10 score on a scale
Standard Error 1.500
|
-8.96 score on a scale
Standard Error 1.601
|
-4.47 score on a scale
Standard Error 1.533
|
|
Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score
Change to Week 96
|
-12.74 score on a scale
Standard Error 2.037
|
-11.55 score on a scale
Standard Error 1.994
|
-14.85 score on a scale
Standard Error 2.104
|
-13.36 score on a scale
Standard Error 2.047
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=114 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=114 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score
Change to Week 48
|
-4.51 score on a scale
Standard Error 0.738
|
-2.91 score on a scale
Standard Error 0.712
|
-3.65 score on a scale
Standard Error 0.740
|
-3.72 score on a scale
Standard Error 0.723
|
|
Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score
Change to Week 96
|
-10.25 score on a scale
Standard Error 1.135
|
-9.16 score on a scale
Standard Error 1.112
|
-10.60 score on a scale
Standard Error 1.163
|
-9.21 score on a scale
Standard Error 1.134
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=115 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Change to Week 24
|
-4.83 score on a scale
Standard Error 0.649
|
-5.04 score on a scale
Standard Error 0.637
|
-5.17 score on a scale
Standard Error 0.664
|
-3.52 score on a scale
Standard Error 0.640
|
|
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Change to Week 96
|
-7.78 score on a scale
Standard Error 0.928
|
-6.59 score on a scale
Standard Error 0.901
|
-7.03 score on a scale
Standard Error 0.977
|
-6.79 score on a scale
Standard Error 0.923
|
|
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Change to Week 48
|
-1.37 score on a scale
Standard Error 0.782
|
-1.86 score on a scale
Standard Error 0.746
|
-2.67 score on a scale
Standard Error 0.792
|
-1.85 score on a scale
Standard Error 0.757
|
|
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Change to Week 72
|
-5.95 score on a scale
Standard Error 0.885
|
-6.86 score on a scale
Standard Error 0.862
|
-6.38 score on a scale
Standard Error 0.897
|
-5.27 score on a scale
Standard Error 0.861
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Coding Total Score
Change to Week 24
|
-1.29 score on a scale
Standard Error 0.611
|
-1.40 score on a scale
Standard Error 0.595
|
-1.40 score on a scale
Standard Error 0.623
|
-0.39 score on a scale
Standard Error 0.600
|
|
Change From Baseline Over Time in RBANS - Coding Total Score
Change to Week 48
|
-1.17 score on a scale
Standard Error 0.694
|
-2.38 score on a scale
Standard Error 0.660
|
-3.14 score on a scale
Standard Error 0.698
|
-1.98 score on a scale
Standard Error 0.673
|
|
Change From Baseline Over Time in RBANS - Coding Total Score
Change to Week 72
|
-2.80 score on a scale
Standard Error 0.819
|
-4.58 score on a scale
Standard Error 0.799
|
-4.53 score on a scale
Standard Error 0.828
|
-5.26 score on a scale
Standard Error 0.799
|
|
Change From Baseline Over Time in RBANS - Coding Total Score
Change to Week 96
|
-6.95 score on a scale
Standard Error 0.970
|
-6.70 score on a scale
Standard Error 0.940
|
-7.30 score on a scale
Standard Error 1.016
|
-6.12 score on a scale
Standard Error 0.957
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Digit Span Total Score
Change to Week 24
|
-0.50 score on a scale
Standard Error 0.189
|
-0.78 score on a scale
Standard Error 0.184
|
-0.64 score on a scale
Standard Error 0.193
|
-0.48 score on a scale
Standard Error 0.185
|
|
Change From Baseline Over Time in RBANS - Digit Span Total Score
Change to Week 48
|
-0.65 score on a scale
Standard Error 0.217
|
-0.41 score on a scale
Standard Error 0.204
|
-0.65 score on a scale
Standard Error 0.216
|
-0.75 score on a scale
Standard Error 0.207
|
|
Change From Baseline Over Time in RBANS - Digit Span Total Score
Change to Week 72
|
-0.89 score on a scale
Standard Error 0.201
|
-1.13 score on a scale
Standard Error 0.196
|
-0.79 score on a scale
Standard Error 0.199
|
-0.94 score on a scale
Standard Error 0.194
|
|
Change From Baseline Over Time in RBANS - Digit Span Total Score
Change to Week 96
|
-0.81 score on a scale
Standard Error 0.232
|
-0.83 score on a scale
Standard Error 0.224
|
-0.90 score on a scale
Standard Error 0.239
|
-1.07 score on a scale
Standard Error 0.229
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Change to Week 24
|
0.03 score on a scale
Standard Error 0.293
|
-0.12 score on a scale
Standard Error 0.284
|
-0.20 score on a scale
Standard Error 0.299
|
0.29 score on a scale
Standard Error 0.287
|
|
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Change to Week 48
|
-0.60 score on a scale
Standard Error 0.380
|
-0.01 score on a scale
Standard Error 0.359
|
-0.38 score on a scale
Standard Error 0.379
|
0.07 score on a scale
Standard Error 0.363
|
|
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Change to Week 72
|
-0.77 score on a scale
Standard Error 0.426
|
-1.04 score on a scale
Standard Error 0.412
|
-1.25 score on a scale
Standard Error 0.425
|
-0.57 score on a scale
Standard Error 0.410
|
|
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Change to Week 96
|
-1.48 score on a scale
Standard Error 0.480
|
-1.29 score on a scale
Standard Error 0.462
|
-1.95 score on a scale
Standard Error 0.490
|
-1.63 score on a scale
Standard Error 0.470
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Change to Week 24
|
-0.65 score on a scale
Standard Error 0.264
|
0.06 score on a scale
Standard Error 0.256
|
-0.60 score on a scale
Standard Error 0.268
|
-0.23 score on a scale
Standard Error 0.259
|
|
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Change to Week 48
|
-0.70 score on a scale
Standard Error 0.288
|
-0.22 score on a scale
Standard Error 0.272
|
-1.18 score on a scale
Standard Error 0.288
|
-0.97 score on a scale
Standard Error 0.276
|
|
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Change to Week 72
|
-1.16 score on a scale
Standard Error 0.272
|
-0.68 score on a scale
Standard Error 0.263
|
-1.45 score on a scale
Standard Error 0.272
|
-1.21 score on a scale
Standard Error 0.262
|
|
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Change to Week 96
|
-1.43 score on a scale
Standard Error 0.305
|
-0.86 score on a scale
Standard Error 0.293
|
-1.49 score on a scale
Standard Error 0.310
|
-1.16 score on a scale
Standard Error 0.299
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - List Recognition Total Score
Change to Week 48
|
0.29 score on a scale
Standard Error 0.242
|
0.41 score on a scale
Standard Error 0.227
|
-0.23 score on a scale
Standard Error 0.239
|
0.31 score on a scale
Standard Error 0.231
|
|
Change From Baseline Over Time in RBANS - List Recognition Total Score
Change to Week 72
|
-0.55 score on a scale
Standard Error 0.262
|
-0.48 score on a scale
Standard Error 0.256
|
-0.43 score on a scale
Standard Error 0.260
|
0.13 score on a scale
Standard Error 0.253
|
|
Change From Baseline Over Time in RBANS - List Recognition Total Score
Change to Week 96
|
-1.42 score on a scale
Standard Error 0.281
|
-0.90 score on a scale
Standard Error 0.271
|
-1.04 score on a scale
Standard Error 0.289
|
-1.11 score on a scale
Standard Error 0.279
|
|
Change From Baseline Over Time in RBANS - List Recognition Total Score
Change to Week 24
|
-0.64 score on a scale
Standard Error 0.238
|
-0.38 score on a scale
Standard Error 0.232
|
-0.79 score on a scale
Standard Error 0.242
|
0.09 score on a scale
Standard Error 0.233
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - List Learning Total Score
Change to Week 72
|
-3.32 score on a scale
Standard Error 0.428
|
-3.02 score on a scale
Standard Error 0.415
|
-3.11 score on a scale
Standard Error 0.424
|
-3.18 score on a scale
Standard Error 0.413
|
|
Change From Baseline Over Time in RBANS - List Learning Total Score
Change to Week 96
|
-2.93 score on a scale
Standard Error 0.496
|
-3.23 score on a scale
Standard Error 0.474
|
-3.07 score on a scale
Standard Error 0.503
|
-3.57 score on a scale
Standard Error 0.484
|
|
Change From Baseline Over Time in RBANS - List Learning Total Score
Change to Week 24
|
-0.67 score on a scale
Standard Error 0.359
|
-0.98 score on a scale
Standard Error 0.348
|
-1.14 score on a scale
Standard Error 0.364
|
-0.57 score on a scale
Standard Error 0.350
|
|
Change From Baseline Over Time in RBANS - List Learning Total Score
Change to Week 48
|
-0.36 score on a scale
Standard Error 0.416
|
-1.89 score on a scale
Standard Error 0.392
|
-1.17 score on a scale
Standard Error 0.413
|
-1.27 score on a scale
Standard Error 0.397
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Change to Week 24
|
0.24 score on a scale
Standard Error 0.308
|
-0.05 score on a scale
Standard Error 0.301
|
0.03 score on a scale
Standard Error 0.313
|
0.20 score on a scale
Standard Error 0.301
|
|
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Change to Week 48
|
0.05 score on a scale
Standard Error 0.363
|
-0.53 score on a scale
Standard Error 0.344
|
-0.47 score on a scale
Standard Error 0.363
|
-0.84 score on a scale
Standard Error 0.348
|
|
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Change to Week 72
|
-0.07 score on a scale
Standard Error 0.378
|
-0.60 score on a scale
Standard Error 0.369
|
-0.60 score on a scale
Standard Error 0.377
|
-0.64 score on a scale
Standard Error 0.365
|
|
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Change to Week 96
|
-1.01 score on a scale
Standard Error 0.405
|
-0.99 score on a scale
Standard Error 0.392
|
-1.88 score on a scale
Standard Error 0.424
|
-1.33 score on a scale
Standard Error 0.404
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - List Recall Total Score
Change to Week 24
|
-0.15 score on a scale
Standard Error 0.105
|
-0.01 score on a scale
Standard Error 0.102
|
-0.08 score on a scale
Standard Error 0.106
|
0.04 score on a scale
Standard Error 0.102
|
|
Change From Baseline Over Time in RBANS - List Recall Total Score
Change to Week 48
|
0.05 score on a scale
Standard Error 0.125
|
0.10 score on a scale
Standard Error 0.118
|
-0.10 score on a scale
Standard Error 0.124
|
0.07 score on a scale
Standard Error 0.120
|
|
Change From Baseline Over Time in RBANS - List Recall Total Score
Change to Week 72
|
-0.29 score on a scale
Standard Error 0.084
|
-0.24 score on a scale
Standard Error 0.082
|
-0.27 score on a scale
Standard Error 0.083
|
0.01 score on a scale
Standard Error 0.081
|
|
Change From Baseline Over Time in RBANS - List Recall Total Score
Change to Week 96
|
-0.39 score on a scale
Standard Error 0.096
|
-0.35 score on a scale
Standard Error 0.092
|
-0.31 score on a scale
Standard Error 0.098
|
-0.14 score on a scale
Standard Error 0.095
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Change to Week 72
|
-0.81 score on a scale
Standard Error 0.168
|
-0.63 score on a scale
Standard Error 0.163
|
-0.75 score on a scale
Standard Error 0.167
|
-0.91 score on a scale
Standard Error 0.162
|
|
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Change to Week 96
|
-0.94 score on a scale
Standard Error 0.155
|
-0.65 score on a scale
Standard Error 0.148
|
-0.77 score on a scale
Standard Error 0.157
|
-0.68 score on a scale
Standard Error 0.152
|
|
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Change to Week 24
|
-0.87 score on a scale
Standard Error 0.136
|
-0.85 score on a scale
Standard Error 0.132
|
-0.86 score on a scale
Standard Error 0.138
|
-0.68 score on a scale
Standard Error 0.132
|
|
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Change to Week 48
|
-0.10 score on a scale
Standard Error 0.117
|
-0.09 score on a scale
Standard Error 0.110
|
-0.14 score on a scale
Standard Error 0.116
|
-0.21 score on a scale
Standard Error 0.112
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Change to Week 24
|
-1.90 score on a scale
Standard Error 0.296
|
-1.48 score on a scale
Standard Error 0.288
|
-1.65 score on a scale
Standard Error 0.300
|
-1.47 score on a scale
Standard Error 0.289
|
|
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Change to Week 48
|
-1.00 score on a scale
Standard Error 0.462
|
-0.90 score on a scale
Standard Error 0.434
|
-0.79 score on a scale
Standard Error 0.460
|
-1.03 score on a scale
Standard Error 0.441
|
|
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Change to Week 72
|
-4.50 score on a scale
Standard Error 0.480
|
-4.38 score on a scale
Standard Error 0.465
|
-4.26 score on a scale
Standard Error 0.475
|
-4.07 score on a scale
Standard Error 0.462
|
|
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Change to Week 96
|
-2.87 score on a scale
Standard Error 0.415
|
-2.83 score on a scale
Standard Error 0.397
|
-2.78 score on a scale
Standard Error 0.425
|
-2.29 score on a scale
Standard Error 0.408
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Story Memory Total Score
Change to Week 24
|
-3.13 score on a scale
Standard Error 0.289
|
-2.93 score on a scale
Standard Error 0.280
|
-2.99 score on a scale
Standard Error 0.293
|
-3.06 score on a scale
Standard Error 0.282
|
|
Change From Baseline Over Time in RBANS - Story Memory Total Score
Change to Week 48
|
-1.07 score on a scale
Standard Error 0.341
|
-0.70 score on a scale
Standard Error 0.320
|
-1.01 score on a scale
Standard Error 0.338
|
-1.62 score on a scale
Standard Error 0.324
|
|
Change From Baseline Over Time in RBANS - Story Memory Total Score
Change to Week 72
|
-2.00 score on a scale
Standard Error 0.396
|
-1.84 score on a scale
Standard Error 0.384
|
-2.10 score on a scale
Standard Error 0.393
|
-2.15 score on a scale
Standard Error 0.381
|
|
Change From Baseline Over Time in RBANS - Story Memory Total Score
Change to Week 96
|
-2.67 score on a scale
Standard Error 0.388
|
-2.46 score on a scale
Standard Error 0.372
|
-2.45 score on a scale
Standard Error 0.397
|
-3.31 score on a scale
Standard Error 0.380
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in RBANS - Story Recall Total Score
Change to Week 24
|
-1.01 score on a scale
Standard Error 0.135
|
-0.93 score on a scale
Standard Error 0.131
|
-0.95 score on a scale
Standard Error 0.137
|
-0.93 score on a scale
Standard Error 0.132
|
|
Change From Baseline Over Time in RBANS - Story Recall Total Score
Change to Week 48
|
-0.95 score on a scale
Standard Error 0.186
|
-0.60 score on a scale
Standard Error 0.175
|
-0.69 score on a scale
Standard Error 0.137
|
-0.70 score on a scale
Standard Error 0.178
|
|
Change From Baseline Over Time in RBANS - Story Recall Total Score
Change to Week 72
|
-1.12 score on a scale
Standard Error 0.186
|
-0.90 score on a scale
Standard Error 0.181
|
-1.38 score on a scale
Standard Error 0.185
|
-0.90 score on a scale
Standard Error 0.179
|
|
Change From Baseline Over Time in RBANS - Story Recall Total Score
Change to Week 96
|
-1.10 score on a scale
Standard Error 0.201
|
-0.96 score on a scale
Standard Error 0.192
|
-1.35 score on a scale
Standard Error 0.205
|
-1.28 score on a scale
Standard Error 0.197
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.
The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Change at Week 24
|
-0.83 score on a scale
Standard Error 0.260
|
-0.48 score on a scale
Standard Error 0.252
|
-1.56 score on a scale
Standard Error 0.263
|
-0.60 score on a scale
Standard Error 0.255
|
|
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Change at Week 48
|
-1.81 score on a scale
Standard Error 0.305
|
-1.60 score on a scale
Standard Error 0.290
|
-2.17 score on a scale
Standard Error 0.305
|
-1.78 score on a scale
Standard Error 0.294
|
|
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Change at Week 72
|
-2.92 score on a scale
Standard Error 0.388
|
-2.43 score on a scale
Standard Error 0.375
|
-3.34 score on a scale
Standard Error 0.386
|
-2.83 score on a scale
Standard Error 0.376
|
|
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Change at Week 96
|
-4.06 score on a scale
Standard Error 0.488
|
-3.70 score on a scale
Standard Error 0.469
|
-4.71 score on a scale
Standard Error 0.494
|
-3.95 score on a scale
Standard Error 0.478
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Change at Week 24
|
0.96 score on a scale
Standard Error 0.567
|
0.80 score on a scale
Standard Error 0.551
|
1.92 score on a scale
Standard Error 0.576
|
0.93 score on a scale
Standard Error 0.551
|
|
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Change at Week 36
|
0.84 score on a scale
Standard Error 0.505
|
0.99 score on a scale
Standard Error 0.481
|
1.32 score on a scale
Standard Error 0.502
|
-0.03 score on a scale
Standard Error 0.487
|
|
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Change at Week 72
|
1.52 score on a scale
Standard Error 0.767
|
1.80 score on a scale
Standard Error 0.745
|
3.25 score on a scale
Standard Error 0.765
|
1.34 score on a scale
Standard Error 0.742
|
|
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Change at Week 96
|
2.03 score on a scale
Standard Error 0.794
|
2.53 score on a scale
Standard Error 0.769
|
2.94 score on a scale
Standard Error 0.804
|
2.38 score on a scale
Standard Error 0.784
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48, Week 72, Week 96Population: Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Outcome Measure 10) , MMSE (see description in Outcome Measure 45), and CDR-SB (see description in Outcome Measure 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable.
Outcome measures
| Measure |
ABBV-8E12 300 mg
n=108 Participants
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 Participants
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 Participants
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
Placebo
n=116 Participants
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Change at Week 72
|
0.22 score on a scale
Standard Error 0.024
|
0.22 score on a scale
Standard Error 0.023
|
0.22 score on a scale
Standard Error 0.024
|
0.22 score on a scale
Standard Error 0.023
|
|
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Change at Week 96
|
0.29 score on a scale
Standard Error 0.030
|
0.28 score on a scale
Standard Error 0.029
|
0.35 score on a scale
Standard Error 0.031
|
0.29 score on a scale
Standard Error 0.029
|
|
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Change at Week 24
|
0.08 score on a scale
Standard Error 0.013
|
0.05 score on a scale
Standard Error 0.013
|
0.08 score on a scale
Standard Error 0.014
|
0.05 score on a scale
Standard Error 0.013
|
|
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Change at Week 48
|
0.15 score on a scale
Standard Error 0.018
|
0.13 score on a scale
Standard Error 0.017
|
0.13 score on a scale
Standard Error 0.018
|
0.13 score on a scale
Standard Error 0.018
|
Adverse Events
Placebo
Serious events: 26 serious events
Other events: 83 other events
Deaths: 1 deaths
ABBV-8E12 300 mg
Serious events: 19 serious events
Other events: 68 other events
Deaths: 2 deaths
ABBV-8E12 1000 mg
Serious events: 22 serious events
Other events: 86 other events
Deaths: 2 deaths
ABBV-8E12 2000 mg
Serious events: 17 serious events
Other events: 91 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=116 participants at risk
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
ABBV-8E12 300 mg
n=108 participants at risk
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 participants at risk
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 participants at risk
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Cardiac disorders
SINUS NODE DYSFUNCTION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
NAUSEA
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
STOMACH MASS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
VOMITING
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
General disorders
ASTHENIA
|
0.86%
1/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
General disorders
CHEST PAIN
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
General disorders
PYREXIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
COVID-19
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.8%
2/113 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
ENDOCARDITIS
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
EPIGLOTTITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.6%
3/116 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
FALL
|
2.6%
3/116 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
ATLANTOAXIAL SUBLUXATION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.8%
2/113 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL STROMAL TUMOUR
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATIC ADENOMA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
CEREBRAL MASS EFFECT
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
HEADACHE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
MOTOR NEURONE DISEASE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
NORMAL PRESSURE HYDROCEPHALUS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
PRESYNCOPE
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.7%
3/113 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
THALAMUS HAEMORRHAGE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
AGGRESSION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Renal and urinary disorders
POLYURIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.93%
1/108 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/113 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
Other adverse events
| Measure |
Placebo
n=116 participants at risk
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
|
ABBV-8E12 300 mg
n=108 participants at risk
ABBV-8E12 300 mg every 4 weeks for 96 weeks
|
ABBV-8E12 1000 mg
n=116 participants at risk
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
|
ABBV-8E12 2000 mg
n=113 participants at risk
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
7.8%
9/116 • Number of events 10 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
11.1%
12/108 • Number of events 15 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.6%
10/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.6%
12/113 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
NAUSEA
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
4.6%
5/108 • Number of events 9 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
3.4%
4/116 • Number of events 5 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.8%
10/113 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Gastrointestinal disorders
VOMITING
|
2.6%
3/116 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
4.6%
5/108 • Number of events 5 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.7%
11/113 • Number of events 14 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
General disorders
FATIGUE
|
9.5%
11/116 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.6%
6/108 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.0%
7/116 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
7.1%
8/113 • Number of events 31 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.8%
3/108 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.8%
2/113 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
BRONCHITIS
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.7%
3/113 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/116 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.6%
3/116 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.3%
6/113 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.5%
11/116 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.2%
11/108 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.3%
12/116 • Number of events 16 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.6%
12/113 • Number of events 14 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
SINUSITIS
|
6.9%
8/116 • Number of events 10 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.6%
3/116 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.7%
3/113 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.8%
9/116 • Number of events 13 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.5%
7/108 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.3%
12/116 • Number of events 14 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
15.9%
18/113 • Number of events 19 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.3%
12/116 • Number of events 17 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.2%
11/108 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
11.2%
13/116 • Number of events 16 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.7%
11/113 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
6.9%
8/116 • Number of events 10 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.6%
6/108 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.9%
8/116 • Number of events 8 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
4.4%
5/113 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
FALL
|
19.0%
22/116 • Number of events 39 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
19.4%
21/108 • Number of events 33 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
14.7%
17/116 • Number of events 23 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
22.1%
25/113 • Number of events 37 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
1.7%
2/116 • Number of events 5 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.5%
7/108 • Number of events 8 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.88%
1/113 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
3.7%
4/108 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.2%
7/113 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.8%
9/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.5%
7/108 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.3%
12/116 • Number of events 14 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.8%
10/113 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.0%
7/116 • Number of events 8 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.3%
9/108 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.5%
11/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.7%
11/113 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.86%
1/116 • Number of events 1 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
0.00%
0/108 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.2%
6/116 • Number of events 9 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.8%
2/113 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
CEREBRAL MICROHAEMORRHAGE
|
3.4%
4/116 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.7%
3/113 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
DIZZINESS
|
8.6%
10/116 • Number of events 13 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
13.0%
14/108 • Number of events 20 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
7.8%
9/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
12.4%
14/113 • Number of events 14 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Nervous system disorders
HEADACHE
|
9.5%
11/116 • Number of events 12 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.3%
9/108 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.5%
11/116 • Number of events 15 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
17.7%
20/113 • Number of events 29 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
ANXIETY
|
9.5%
11/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.8%
3/108 • Number of events 4 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
7.8%
9/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
14.2%
16/113 • Number of events 17 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
DEPRESSION
|
9.5%
11/116 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
9.3%
10/108 • Number of events 10 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.9%
8/116 • Number of events 10 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
10.6%
12/113 • Number of events 13 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Psychiatric disorders
INSOMNIA
|
2.6%
3/116 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.5%
7/108 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.7%
3/113 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.0%
7/116 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
2.8%
3/108 • Number of events 3 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
6.0%
7/116 • Number of events 7 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
8.0%
9/113 • Number of events 11 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
|
Vascular disorders
HYPERTENSION
|
1.7%
2/116 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
1.9%
2/108 • Number of events 2 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
5.2%
6/116 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
4.4%
5/113 • Number of events 6 • From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
|
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