Trial Outcomes & Findings for An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD) (NCT NCT03712787)

Last Updated: 2022-09-22

Results Overview

Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

364 participants

Primary outcome timeframe

From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Results posted on

2022-09-22

Participant Flow

A total of 364 participants who had completed the parent study (Study M15-566; NCT02880956) were enrolled into this extension study from a total of 57 sites in the United States, Australia, Belgium, Canada, Denmark, Finland, Italy, New Zealand, Spain, and Sweden.

Prior to enrollment, 87 participants had received tilavonemab 300 mg, 97 participants had received tilavonemab 1000 mg, 88 participants had received tilavonemab 2000 mg, and 92 participants had received placebo in the parent study. One enrolled participant did not receive any study drug and was not included in any analysis.

Participant milestones

Participant milestones
Measure	300 mg/1000 mg Tilavonemab Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Overall Study STARTED	87	97	88	91
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	87	97	88	91

Reasons for withdrawal

Reasons for withdrawal
Measure	300 mg/1000 mg Tilavonemab Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Overall Study Adverse Event	2	3	0	4
Overall Study Withdrawal by Subject	4	14	12	8
Overall Study Lost to Follow-up	1	1	2	1
Overall Study COVID-19 Logistical Restrictions	1	1	0	0
Overall Study COVID-19 Infection	0	1	0	0
Overall Study Other, Not Specified	79	77	74	78

Baseline Characteristics

An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 mg/1000 mg Tilavonemab n=87 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	Total n=363 Participants Total of all reporting groups
Age, Customized < 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	43 Participants n=21 Participants
Age, Customized >= 65 years	79 Participants n=5 Participants	86 Participants n=7 Participants	74 Participants n=5 Participants	81 Participants n=4 Participants	320 Participants n=21 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	48 Participants n=7 Participants	48 Participants n=5 Participants	56 Participants n=4 Participants	191 Participants n=21 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	49 Participants n=7 Participants	40 Participants n=5 Participants	35 Participants n=4 Participants	172 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	94 Participants n=7 Participants	86 Participants n=5 Participants	89 Participants n=4 Participants	350 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 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	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized None	82 Participants n=5 Participants	93 Participants n=7 Participants	85 Participants n=5 Participants	87 Participants n=4 Participants	347 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Population: Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.

Outcome measures

Outcome measures
Measure	300 mg/1000 mg Tilavonemab n=87 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs Any TEAE	54 Participants	66 Participants	59 Participants	57 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs Severe TEAE	9 Participants	8 Participants	10 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs TEAE With a Reasonable Possibility of Relationship to Study Drug	7 Participants	10 Participants	15 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs Serious TEAE	16 Participants	11 Participants	12 Participants	10 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs TEAE Leading to Discontinuation of Study Drug	2 Participants	4 Participants	0 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs Fatal TEAE	1 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Population: Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.

Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	300 mg/1000 mg Tilavonemab n=87 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Hemoglobin - Low (< 100 g/L)	1 Participants	0 Participants	2 Participants	1 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Hemoglobin - High (> 40 g/L above Upper Limit of Normal [ULN])	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Platelets - Low (< 75 × 10^9/L)	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Leukocytes - Low (< 2 × 10^9/L)	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Leukocytes - High (> 100 × 10^9/L)	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Neutrophils - Low (< 1 × 10^9/L)	1 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Lymphocytes - Low (< 0.5 × 10^9/L)	0 Participants	0 Participants	1 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Lymphocytes - High (> 20 × 10^9/L)	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Activated Partial Thromboplastin Time (> ULN)	0 Participants	0 Participants	0 Participants	0 Participants
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Prothrombin International Normalized Ratio (> ULN)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Population: Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.

Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03

Outcome measures

Outcome measures
Measure	300 mg/1000 mg Tilavonemab n=87 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Albumin (< 20 g/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Sodium - High (> 155 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Potassium - Low (< 3 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Potassium - High (> 6 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Glucose - Low (< 2.2 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Glucose - High (> 13.9 mmol/L)	0 Participants	0 Participants	0 Participants	1 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Cholesterol (> 12.92 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Triglycerides (> 5.7 mmol/L)	0 Participants	0 Participants	1 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Phosphate (< 0.6 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Uric acid (> 590 μmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Alanine Aminotransferase (> 3 × ULN)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Aspartate Aminotransferase (> 3 × ULN)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Alkaline Phosphatase (> 2.5 × ULN)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Bilirubin (> 1.5 × ULN)	0 Participants	0 Participants	1 Participants	1 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Creatinine (> 1.5 × ULN)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Calcium - Low (< 1.75 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Calcium - High (> 3.1 mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Sodium - Low (< 130 mmol/L)	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Population: Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.

The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.

Outcome measures

Outcome measures
Measure	300 mg/1000 mg Tilavonemab n=87 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period Suicidal behaviors or ideations	4 Participants	3 Participants	8 Participants	4 Participants
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period Suicidal behaviors	0 Participants	0 Participants	0 Participants	0 Participants
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period Suicidal ideations	4 Participants	3 Participants	8 Participants	4 Participants
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period Suicidal ideations only (No Suicidal Behavior)	4 Participants	3 Participants	8 Participants	4 Participants

PRIMARY outcome

Timeframe: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Population: Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. Participants with postbaseline value for the respective parameter.

Outcome measures

Outcome measures
Measure	300 mg/1000 mg Tilavonemab n=79 Participants Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=84 Participants Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=79 Participants Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=78 Participants Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease Cerebral Edemas	1 Participants	1 Participants	0 Participants	0 Participants
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease Questionable Cerebral Edemas	0 Participants	1 Participants	0 Participants	0 Participants
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease New Microhemorrhage(s)	4 Participants	5 Participants	11 Participants	5 Participants
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease Severe White Matter Disease	9 Participants	5 Participants	6 Participants	5 Participants

Adverse Events

300 mg/1000 mg Tilavonemab

Serious events: 16 serious events

Other events: 26 other events

Deaths: 2 deaths

1000 mg/1000 mg Tilavonemab

Serious events: 11 serious events

Other events: 37 other events

Deaths: 1 deaths

2000 mg/2000 mg Tilavonemab

Serious events: 12 serious events

Other events: 33 other events

Deaths: 1 deaths

PBO/2000 mg Tilavonemab

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	300 mg/1000 mg Tilavonemab n=87 participants at risk Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.	1000 mg/1000 mg Tilavonemab n=97 participants at risk Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	2000 mg/2000 mg Tilavonemab n=88 participants at risk Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.	PBO/2000 mg Tilavonemab n=91 participants at risk Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
Gastrointestinal disorders DIARRHOEA	5.7% 5/87 • Number of events 5 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.2% 5/97 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	3.4% 3/88 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	1.1% 1/91 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Infections and infestations URINARY TRACT INFECTION	4.6% 4/87 • Number of events 10 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	8.2% 8/97 • Number of events 8 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	0.00% 0/88 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	1.1% 1/91 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Injury, poisoning and procedural complications CONTUSION	2.3% 2/87 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	6.2% 6/97 • Number of events 8 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	1.1% 1/88 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	0.00% 0/91 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Injury, poisoning and procedural complications FALL	11.5% 10/87 • Number of events 14 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	10.3% 10/97 • Number of events 12 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	13.6% 12/88 • Number of events 16 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	11.0% 10/91 • Number of events 13 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.1% 1/87 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.1% 2/97 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	6.8% 6/88 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.2% 2/91 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Musculoskeletal and connective tissue disorders BACK PAIN	5.7% 5/87 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	4.1% 4/97 • Number of events 4 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	3.4% 3/88 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.5% 5/91 • Number of events 7 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Nervous system disorders DIZZINESS	5.7% 5/87 • Number of events 5 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.1% 2/97 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.3% 2/88 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.2% 2/91 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Psychiatric disorders AGITATION	1.1% 1/87 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	6.2% 6/97 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.3% 2/88 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	0.00% 0/91 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Psychiatric disorders ANXIETY	3.4% 3/87 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	1.0% 1/97 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	8.0% 7/88 • Number of events 8 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	3.3% 3/91 • Number of events 3 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Psychiatric disorders CONFUSIONAL STATE	1.1% 1/87 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.1% 2/97 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	4.5% 4/88 • Number of events 4 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.5% 5/91 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Psychiatric disorders DELUSION	0.00% 0/87 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	1.0% 1/97 • Number of events 1 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.7% 5/88 • Number of events 5 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	2.2% 2/91 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Vascular disorders HYPERTENSION	2.3% 2/87 • Number of events 2 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.2% 5/97 • Number of events 5 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	5.7% 5/88 • Number of events 6 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	0.00% 0/91 • All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

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