Trial Outcomes & Findings for A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (NCT NCT04592874)

NCT ID: NCT04592874

Last Updated: 2025-10-29

Results Overview

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 356 participants
• Primary outcome timeframe: Study completion up to 96 weeks
• Results posted on: 2025-10-29

Participant Flow

Approximately 328 participants were planned to be enrolled: Part 1: Approximately 40 participants were to be randomized in a 1:1:1:1 ratio to receive either 15 mg/kg AL002, 40 mg/kg AL002, 60 mg/kg AL002, or placebo. Part 2: Approximately 288 participants were to be enrolled with the same allocation ratio (1:1:1:1) used in Part 1.

Screening period of up to 8 weeks prior to the optional Predose Baseline Visit or to Day 1 visit.

Participant milestones

Measure	AL002 Dose 1: 15 mg/kg AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg AL002 every 4 weeks	Placebo Placebo every 4 weeks
Overall Study STARTED	97	94	77	88
Overall Study COMPLETED	51	53	50	72
Overall Study NOT COMPLETED	46	41	27	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This field outlines the age categories of the participants per arm

Baseline characteristics by cohort

Measure	AL002 Dose 1: 15 mg/kg n=97 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=94 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=77 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks	Total n=356 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • This field outlines the age categories of the participants per arm	0 Participants n=7 Participants • This field outlines the age categories of the participants per arm	0 Participants n=5 Participants • This field outlines the age categories of the participants per arm	0 Participants n=4 Participants • This field outlines the age categories of the participants per arm	0 Participants n=21 Participants • This field outlines the age categories of the participants per arm
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants • This field outlines the age categories of the participants per arm	24 Participants n=7 Participants • This field outlines the age categories of the participants per arm	15 Participants n=5 Participants • This field outlines the age categories of the participants per arm	15 Participants n=4 Participants • This field outlines the age categories of the participants per arm	78 Participants n=21 Participants • This field outlines the age categories of the participants per arm
Age, Categorical >=65 years	73 Participants n=5 Participants • This field outlines the age categories of the participants per arm	70 Participants n=7 Participants • This field outlines the age categories of the participants per arm	62 Participants n=5 Participants • This field outlines the age categories of the participants per arm	73 Participants n=4 Participants • This field outlines the age categories of the participants per arm	278 Participants n=21 Participants • This field outlines the age categories of the participants per arm
Sex: Female, Male Female	45 Participants n=5 Participants • This field outlines the sex of the participants per arm	52 Participants n=7 Participants • This field outlines the sex of the participants per arm	39 Participants n=5 Participants • This field outlines the sex of the participants per arm	44 Participants n=4 Participants • This field outlines the sex of the participants per arm	180 Participants n=21 Participants • This field outlines the sex of the participants per arm
Sex: Female, Male Male	52 Participants n=5 Participants • This field outlines the sex of the participants per arm	42 Participants n=7 Participants • This field outlines the sex of the participants per arm	38 Participants n=5 Participants • This field outlines the sex of the participants per arm	44 Participants n=4 Participants • This field outlines the sex of the participants per arm	176 Participants n=21 Participants • This field outlines the sex of the participants per arm
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=7 Participants • This field outlines the race of the participants per arm	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=4 Participants • This field outlines the race of the participants per arm	0 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) Asian	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=7 Participants • This field outlines the race of the participants per arm	2 Participants n=5 Participants • This field outlines the race of the participants per arm	1 Participants n=4 Participants • This field outlines the race of the participants per arm	3 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=7 Participants • This field outlines the race of the participants per arm	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=4 Participants • This field outlines the race of the participants per arm	0 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=7 Participants • This field outlines the race of the participants per arm	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=4 Participants • This field outlines the race of the participants per arm	3 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) White	88 Participants n=5 Participants • This field outlines the race of the participants per arm	92 Participants n=7 Participants • This field outlines the race of the participants per arm	72 Participants n=5 Participants • This field outlines the race of the participants per arm	82 Participants n=4 Participants • This field outlines the race of the participants per arm	334 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • This field outlines the race of the participants per arm	0 Participants n=7 Participants • This field outlines the race of the participants per arm	0 Participants n=5 Participants • This field outlines the race of the participants per arm	1 Participants n=4 Participants • This field outlines the race of the participants per arm	1 Participants n=21 Participants • This field outlines the race of the participants per arm
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants • This field outlines the race of the participants per arm	2 Participants n=7 Participants • This field outlines the race of the participants per arm	3 Participants n=5 Participants • This field outlines the race of the participants per arm	4 Participants n=4 Participants • This field outlines the race of the participants per arm	15 Participants n=21 Participants • This field outlines the race of the participants per arm
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants • This is the ethnicity of the participants per arm	5 Participants n=7 Participants • This is the ethnicity of the participants per arm	4 Participants n=5 Participants • This is the ethnicity of the participants per arm	4 Participants n=4 Participants • This is the ethnicity of the participants per arm	17 Participants n=21 Participants • This is the ethnicity of the participants per arm
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants • This is the ethnicity of the participants per arm	86 Participants n=7 Participants • This is the ethnicity of the participants per arm	70 Participants n=5 Participants • This is the ethnicity of the participants per arm	81 Participants n=4 Participants • This is the ethnicity of the participants per arm	324 Participants n=21 Participants • This is the ethnicity of the participants per arm
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants • This is the ethnicity of the participants per arm	3 Participants n=7 Participants • This is the ethnicity of the participants per arm	3 Participants n=5 Participants • This is the ethnicity of the participants per arm	3 Participants n=4 Participants • This is the ethnicity of the participants per arm	15 Participants n=21 Participants • This is the ethnicity of the participants per arm

PRIMARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96.

The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Week 24 Change from Baseline	1.02 Score on a scale Standard Error 0.197	0.80 Score on a scale Standard Error 0.190	1.07 Score on a scale Standard Error 0.196	1.15 Score on a scale Standard Error 0.180
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Week 48 Change from Baseline	1.68 Score on a scale Standard Error 0.256	1.61 Score on a scale Standard Error 0.256	1.95 Score on a scale Standard Error 0.259	1.68 Score on a scale Standard Error 0.236
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Week 72 Change from Baseline	2.61 Score on a scale Standard Error 0.366	2.93 Score on a scale Standard Error 0.358	2.12 Score on a scale Standard Error 0.372	2.25 Score on a scale Standard Error 0.324
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Week 96 Change from Baseline	3.17 Score on a scale Standard Error 0.488	3.61 Score on a scale Standard Error 0.498	3.31 Score on a scale Standard Error 0.506	3.48 Score on a scale Standard Error 0.435

SECONDARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96

The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Change in Mini-Mental Status Examination (MMSE) Score Week 24 Change from Baseline	-2.70 Score on a scale Standard Error 0.396	-3.03 Score on a scale Standard Error 0.381	-2.78 Score on a scale Standard Error 0.393	-2.65 Score on a scale Standard Error 0.364
Change in Mini-Mental Status Examination (MMSE) Score Week 48 Change from Baseline	-4.06 Score on a scale Standard Error 0.541	-3.91 Score on a scale Standard Error 0.535	-3.74 Score on a scale Standard Error 0.549	-3.33 Score on a scale Standard Error 0.501
Change in Mini-Mental Status Examination (MMSE) Score Week 72 Change from Baseline	-5.15 Score on a scale Standard Error 0.772	-5.47 Score on a scale Standard Error 0.751	-4.99 Score on a scale Standard Error 0.780	-4.89 Score on a scale Standard Error 0.692
Change in Mini-Mental Status Examination (MMSE) Score Week 96 Change from Baseline	-5.88 Score on a scale Standard Error 0.906	-7.22 Score on a scale Standard Error 0.914	-5.81 Score on a scale Standard Error 0.932	-5.47 Score on a scale Standard Error 0.814

SECONDARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96

The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score Week 96 Change from Baseline	-8.12 Score on a scale Standard Error 1.915	-7.23 Score on a scale Standard Error 2.011	-6.56 Score on a scale Standard Error 1.936	-7.47 Score on a scale Standard Error 1.574
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score Week 24 Change from Baseline	-3.37 Score on a scale Standard Error 0.857	-2.34 Score on a scale Standard Error 0.820	-2.65 Score on a scale Standard Error 0.870	-3.05 Score on a scale Standard Error 0.782
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score Week 48 Change from Baseline	-7.15 Score on a scale Standard Error 0.939	-6.13 Score on a scale Standard Error 0.921	-5.78 Score on a scale Standard Error 0.957	-5.05 Score on a scale Standard Error 0.844
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score Week 72 Change from Baseline	-6.46 Score on a scale Standard Error 1.339	-6.56 Score on a scale Standard Error 1.281	-5.94 Score on a scale Standard Error 1.357	-5.86 Score on a scale Standard Error 1.149

SECONDARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96

The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score Week 24 Change from Baseline	1.09 Score on a scale Standard Error 0.710	3.04 Score on a scale Standard Error 0.697	3.54 Score on a scale Standard Error 0.717	1.93 Score on a scale Standard Error 0.659
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score Week 48 Change from Baseline	3.86 Score on a scale Standard Error 0.960	6.06 Score on a scale Standard Error 0.950	5.67 Score on a scale Standard Error 0.967	3.79 Score on a scale Standard Error 0.880
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score Week 72 Change from Baseline	7.31 Score on a scale Standard Error 1.325	8.30 Score on a scale Standard Error 1.285	7.34 Score on a scale Standard Error 1.321	6.26 Score on a scale Standard Error 1.205
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score Week 96 Change from Baseline	9.59 Score on a scale Standard Error 1.543	10.02 Score on a scale Standard Error 1.541	11.55 Score on a scale Standard Error 1.563	8.62 Score on a scale Standard Error 1.397

SECONDARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96

The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score Week 24 Change from Baseline	-1.60 Score on a scale Standard Error 0.608	-0.99 Score on a scale Standard Error 0.594	-2.45 Score on a scale Standard Error 0.607	-0.67 Score on a scale Standard Error 0.559
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score Week 48 Change from Baseline	-2.95 Score on a scale Standard Error 0.808	-3.11 Score on a scale Standard Error 0.811	-3.46 Score on a scale Standard Error 0.828	-2.73 Score on a scale Standard Error 0.744
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score Week 72 Change from Baseline	-6.41 Score on a scale Standard Error 1.183	-6.57 Score on a scale Standard Error 1.159	-6.80 Score on a scale Standard Error 1.201	-5.36 Score on a scale Standard Error 1.063
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score Week 96 Change from Baseline	-8.50 Score on a scale Standard Error 1.517	-7.80 Score on a scale Standard Error 1.549	-7.44 Score on a scale Standard Error 1.570	-7.97 Score on a scale Standard Error 1.368

SECONDARY outcome

Timeframe: Study completion up to 96 weeks

Population: Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96

The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.

Outcome measures

Measure	AL002 Dose 1: 15 mg/kg n=89 Participants AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=87 Participants AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=92 Participants AL002 every 4 weeks	Placebo n=88 Participants Placebo every 4 weeks
Change in Alzheimer's Disease Composite Score (ADCOMS) Score Week 24 Change from Baseline	0.11 Score on a scale Standard Error 0.020	0.11 Score on a scale Standard Error 0.019	0.14 Score on a scale Standard Error 0.020	0.13 Score on a scale Standard Error 0.018
Change in Alzheimer's Disease Composite Score (ADCOMS) Score Week 48 Change from Baseline	0.19 Score on a scale Standard Error 0.027	0.20 Score on a scale Standard Error 0.027	0.25 Score on a scale Standard Error 0.027	0.20 Score on a scale Standard Error 0.024
Change in Alzheimer's Disease Composite Score (ADCOMS) Score Week 72 Change from Baseline	0.25 Score on a scale Standard Error 0.041	0.36 Score on a scale Standard Error 0.039	0.25 Score on a scale Standard Error 0.040	0.26 Score on a scale Standard Error 0.036
Change in Alzheimer's Disease Composite Score (ADCOMS) Score Week 96 Change from Baseline	0.32 Score on a scale Standard Error 0.052	0.43 Score on a scale Standard Error 0.052	0.39 Score on a scale Standard Error 0.053	0.35 Score on a scale Standard Error 0.047

Adverse Events

AL002 Dose 1: 15 mg/kg

Serious events: 14 serious events

Other events: 66 other events

Deaths: 1 deaths

AL002 Dose 2: 40 mg/kg

Serious events: 12 serious events

Other events: 75 other events

Deaths: 1 deaths

AL002 Dose 3: 60 mg/kg

Serious events: 10 serious events

Other events: 59 other events

Deaths: 1 deaths

Placebo

Serious events: 7 serious events

Other events: 64 other events

Deaths: 1 deaths

Serious adverse events

Measure	AL002 Dose 1: 15 mg/kg n=97 participants at risk AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=94 participants at risk AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=77 participants at risk AL002 every 4 weeks	Placebo n=88 participants at risk Placebo every 4 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Vascular disorders Deep vein thrombosis	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Immune system disorders Anaphylactic reaction	2.1% 2/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Psychiatric disorders Confusional state	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Psychiatric disorders Aggression	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Joint injury	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Skin wound	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Fall	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Cardiac disorders Atrial fibrillation	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Cardiac disorders Cardiac failure congestive	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Cardiac disorders Myocardial infarction	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Syncope	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Amyloid related imaging abnormality - edema/effusion	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Amyloid related imaging abnormality - microhaemorrhages and haemosiderin deposits	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Aphasia	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Cerebrovascular accident	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Epilepsy	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Headache	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Loss of consciousness	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Polyneuropathy	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Eye disorders Glaucoma	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Diverticular perforation	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Inguinal hernia	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Rectal haemorrhage	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Vomiting	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Hepatobiliary disorders Biliary obstruction	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Hepatobiliary disorders Jaundice	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Renal and urinary disorders Hydronephrosis	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Renal and urinary disorders Urinary retention	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Colonic abscess	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Gastroenteritis	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Parotitis	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Pneumonia	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Sepsis	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Urinary tract infection	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Diverticulitis	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Escherichia bacteraemia	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Metabolism and nutrition disorders Dehydration	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.

Other adverse events

Measure	AL002 Dose 1: 15 mg/kg n=97 participants at risk AL002 every 4 weeks	AL002 Dose 2: 40 mg/kg n=94 participants at risk AL002 every 4 weeks	AL002 Dose 3: 60 mg/kg n=77 participants at risk AL002 every 4 weeks	Placebo n=88 participants at risk Placebo every 4 weeks
Injury, poisoning and procedural complications Fall	5.2% 5/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	20.2% 19/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	9.1% 7/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	12.5% 11/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Injury, poisoning and procedural complications Infusion related reaction	2.1% 2/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	9.6% 9/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	13.0% 10/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	2.3% 2/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Vascular disorders Hypertension	4.1% 4/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.4% 6/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	9.1% 7/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.8% 6/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Amyloid related imaging abnormality-microhaemorrages and haemosiderin deposits	28.9% 28/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	29.8% 28/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	27.3% 21/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.5% 4/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Amyloid related imaging abnormality-edema/effusion	21.6% 21/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	23.4% 22/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	22.1% 17/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Headache	10.3% 10/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	13.8% 13/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	5.2% 4/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	11.4% 10/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Dizziness	6.2% 6/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	7.4% 7/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	7.8% 6/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	8.0% 7/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Nervous system disorders Syncope	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	2.1% 2/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.8% 6/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
General disorders Fatigue	3.1% 3/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.3% 4/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	5.2% 4/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.5% 4/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Eye disorders Cataract	7.2% 7/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.4% 6/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	9.1% 7/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.4% 3/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Vomiting	6.2% 6/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	8.5% 8/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	9.1% 7/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.1% 1/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Nausea	5.2% 5/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.4% 6/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	11.7% 9/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.5% 4/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Gastrointestinal disorders Diarrhoea	6.2% 6/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.3% 4/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	1.3% 1/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	8.0% 7/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Psychiatric disorders Confusional state	1.0% 1/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.2% 3/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	0.00% 0/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	5.7% 5/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Musculoskeletal and connective tissue disorders Back pain	5.2% 5/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.2% 3/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.9% 3/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.4% 3/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 3/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.2% 3/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	3.9% 3/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.8% 6/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Covid-19	11.3% 11/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	12.8% 12/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	16.9% 13/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	21.6% 19/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Nasopharyngitis	6.2% 6/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	2.1% 2/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.5% 5/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.5% 4/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Upper respiratory tract infection	3.1% 3/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	5.3% 5/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	6.5% 5/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	8.0% 7/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.
Infections and infestations Urinary tract infection	5.2% 5/97 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	4.3% 4/94 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	2.6% 2/77 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.	5.7% 5/88 • Adverse events (AE) have been reported from the screening period up to 8 weeks prior to dosing through 8 weeks after the last dose administration which could be up to 115 weeks of study participation.

Additional Information

Alector Medical Information

Alector

Phone: 650-826-2454

Email: medinfo@alector.com

Results disclosure agreements

• Principal investigator is a sponsor employee Alector's agreements with principal investigators may vary but will not prohibit any investigator from publishing. Alector supports the publication of the results from all centers in a multi-center trial, and its agreements include provisions to enable the multi-center publication to occur before publication of data from a single site.
• Publication restrictions are in place

Restriction type: OTHER