Trial Outcomes & Findings for ELND005 in Patients With Mild to Moderate Alzheimer's Disease (NCT NCT00568776)

NCT ID: NCT00568776

Last Updated: 2019-11-01

Results Overview

The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 353 participants
• Primary outcome timeframe: Baseline and 78 weeks
• Results posted on: 2019-11-01

Participant Flow

Participant milestones

Measure	Placebo BID oral administration for 78 weeks	ELND005 250 mg BID oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Overall Study STARTED	83	88	89	91
Overall Study COMPLETED	53	52	15	19
Overall Study NOT COMPLETED	30	36	74	72

Reasons for withdrawal

Measure	Placebo BID oral administration for 78 weeks	ELND005 250 mg BID oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Overall Study Adverse Event	8	8	10	8
Overall Study Death	0	1	4	3
Overall Study Physician Decision	0	2	0	0
Overall Study Lack of Efficacy	2	2	2	4
Overall Study Lost to Follow-up	1	1	1	1
Overall Study Protocol Violation	1	0	1	1
Overall Study Withdrawal by Subject	13	15	13	7
Overall Study Loss of Caregiver	0	2	1	2
Overall Study Sponsor Decision	2	2	41	42
Overall Study Miscellaeneous	3	3	1	4

Baseline Characteristics

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

Baseline characteristics by cohort

Measure	Placebo BID n=83 Participants oral administration for 78 weeks	ELND005 250 mg BID n=88 Participants oral administration for 78 weeks	ELND005 1000 mg BID n=89 Participants oral administration for 78 weeks	ELND005 2000 mg BID n=91 Participants oral administration for 78 weeks	Total n=351 Participants Total of all reporting groups
Age, Continuous	73.4 years STANDARD_DEVIATION 7.83 • n=5 Participants	73.4 years STANDARD_DEVIATION 7.26 • n=7 Participants	73.4 years STANDARD_DEVIATION 7.56 • n=5 Participants	72.2 years STANDARD_DEVIATION 8.20 • n=4 Participants	73.1 years STANDARD_DEVIATION 7.7 • n=21 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	51 Participants n=7 Participants	48 Participants n=5 Participants	51 Participants n=4 Participants	197 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	154 Participants n=21 Participants
Region of Enrollment United States	68 patients n=5 Participants	75 patients n=7 Participants	71 patients n=5 Participants	75 patients n=4 Participants	289 patients n=21 Participants
Region of Enrollment Canada	15 patients n=5 Participants	13 patients n=7 Participants	18 patients n=5 Participants	16 patients n=4 Participants	62 patients n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 78 weeks

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.

Outcome measures

Measure	Placebo BID n=82 Participants oral administration for 78 weeks	ELND005 250 mg BID n=84 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)	-0.383 Scores on a Scale Standard Error 0.075	-0.350 Scores on a Scale Standard Error 0.074	—	—

PRIMARY outcome

Timeframe: Baseline and 78 weeks

Population: Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.

The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.

Outcome measures

Measure	Placebo BID n=47 Participants oral administration for 78 weeks	ELND005 250 mg BID n=49 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)	-0.369 Scores on a Scale Standard Error 0.093	-0.222 Scores on a Scale Standard Error 0.095	—	—

PRIMARY outcome

Timeframe: Baseline and 78 weeks

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.

Outcome measures

Measure	Placebo BID n=82 Participants oral administration for 78 weeks	ELND005 250 mg BID n=84 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)	-9.467 Scores on a Scale Standard Error 1.641	-10.861 Scores on a Scale Standard Error 1.604	—	—

PRIMARY outcome

Timeframe: Baseline and 78 weeks

Population: Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.

The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.

Outcome measures

Measure	Placebo BID n=47 Participants oral administration for 78 weeks	ELND005 250 mg BID n=49 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)	-9.635 Scores on a Scale Standard Error 1.779	-8.987 Scores on a Scale Standard Error 1.760	—	—

SECONDARY outcome

Timeframe: Baseline and 78 weeks

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.

Outcome measures

Measure	Placebo BID n=82 Participants oral administration for 78 weeks	ELND005 250 mg BID n=84 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)	-8.239 Scores on a Scale Standard Error 1.531	-10.796 Scores on a Scale Standard Error 1.540	—	—

SECONDARY outcome

Timeframe: Baseline and 78 weeks

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.

Outcome measures

Measure	Placebo BID n=82 Participants oral administration for 78 weeks	ELND005 250 mg BID n=84 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)	-2.742 Scores on a Scale Standard Error 0.363	-2.452 Scores on a Scale Standard Error 0.357	—	—

SECONDARY outcome

Timeframe: Baseline and 78 weeks

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.

Outcome measures

Measure	Placebo BID n=82 Participants oral administration for 78 weeks	ELND005 250 mg BID n=84 Participants oral administration for 78 weeks	ELND005 1000 mg BID oral administration for 78 weeks	ELND005 2000 mg BID oral administration for 78 weeks
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)	-6.132 Scores on a Scale Standard Error 1.851	-5.116 Scores on a Scale Standard Error 1.814	—	—

Adverse Events

Placebo BID

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

ELND005 250 mg BID

Serious events: 19 serious events

Other events: 46 other events

Deaths: 0 deaths

ELND005 1000 mg BID

Serious events: 20 serious events

Other events: 45 other events

Deaths: 0 deaths

ELND005 2000 mg BID

Serious events: 21 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo BID n=83 participants at risk oral administration for 78 weeks	ELND005 250 mg BID n=88 participants at risk oral administration for 78 weeks	ELND005 1000 mg BID n=89 participants at risk oral administration for 78 weeks	ELND005 2000 mg BID n=91 participants at risk oral administration for 78 weeks
Cardiac disorders Angina Unstable	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Atrial Fribrillation	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Atrial Futter	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Cardiac Arrest	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Coronary Artery Occlusion	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Myocardial Infarction	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Eye disorders Glaucoma	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Eye disorders Retinal Vein Occlusion	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Eye disorders Vitreous Haemorrhage	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Gastritis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Gastritis Hemorrhagic	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Pancreatitis	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
General disorders Hypothermia	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
General disorders Sudden Death	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Hepatobiliary disorders Cholecystitis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Arthritis Bacterial	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Bacterial Sepsis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Kidney Infection	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Pneumonia	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.3% 3/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Pneumonia Bacterial	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Staphylococcal Infection	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Urinary Tract Infection	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.3% 3/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Urosepsis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Viral Infection	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Compression Fracture	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Contusion	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Fall	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Laceration	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Postoperative Ileus	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Subdural Hematoma	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Investigations Electrocardiogram Change	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Investigations Hepatic Enzyme Increased	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Investigations Lipase Increased	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Metabolism and nutrition disorders Dehydration	2.4% 2/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.4% 3/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer In Situ	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Carotid Artery Occlusion	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Cerebral Hemorrhage	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Cerebrovascular Accident	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Dementia Alzheimer's Type	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Dizziness	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Encephalopathy	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Haemorrhagic Stroke	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Ischaemic Cerebral Infarction	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Syncope	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Acute Psychosis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Agitation	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Confusional State	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Delirium	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Mental Status Changes	1.2% 1/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Psychotic Disorder	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Renal and urinary disorders Renal Failure Acute	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Renal and urinary disorders Urinary Retention	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Vascular disorders Aortic Thrombosis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Vascular disorders Deep Vein Thrombosis	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.00% 0/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	1.1% 1/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.

Other adverse events

Measure	Placebo BID n=83 participants at risk oral administration for 78 weeks	ELND005 250 mg BID n=88 participants at risk oral administration for 78 weeks	ELND005 1000 mg BID n=89 participants at risk oral administration for 78 weeks	ELND005 2000 mg BID n=91 participants at risk oral administration for 78 weeks
Psychiatric disorders Depression	4.8% 4/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.4% 10/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	13.2% 12/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Insomnia	6.0% 5/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.4% 3/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	2.2% 2/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	8.8% 8/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Diarrhoea	7.2% 6/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	10.2% 9/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	9.0% 8/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	13.2% 12/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Nausea	4.8% 4/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	9.1% 8/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.4% 3/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	15.4% 14/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Vomiting	3.6% 3/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	5.7% 5/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.4% 3/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	8.8% 8/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
General disorders Fatigue	4.8% 4/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	6.8% 6/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	6.7% 6/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 7/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Urinary Tract Infection	8.4% 7/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	13.6% 12/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	12.1% 11/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Fall	6.0% 5/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	12.5% 11/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.2% 10/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	15.4% 14/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Dizziness	8.4% 7/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	6.7% 6/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	12.1% 11/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Headache	14.5% 12/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	12.4% 11/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	8.8% 8/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Agitation	6.0% 5/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	10.1% 9/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	6.6% 6/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Confusional State	3.6% 3/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	8.0% 7/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.5% 4/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	4.4% 4/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Upper Respiratory Tract Infection	6.0% 5/83 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	10.2% 9/88 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.4% 3/89 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.3% 3/91 • Reported adverse events include events starting at or after Screening to Week 84 For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.

Additional Information

Aleksandra pastrak, MD, PhD, Vice President, Clinical Development

Transition Therapeutics Ireland Limited

Phone: +1 416 263 1227

Email: apastrak@transitiontherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator may publish after release of multi-center study publication, or 18 months after database lock of overall study. Sponsor has 60 days to review any proposed publication and request removal of Sponsor's confidential information. Sponsor may request an additional 90 days if filing a patent.
• Publication restrictions are in place

Restriction type: OTHER