Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease (NCT NCT03289143)

Last Updated: 2022-03-16

Results Overview

The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

457 participants

Primary outcome timeframe

Baseline and 73 Weeks

Results posted on

2022-03-16

Participant Flow

The study consisted of a double-blind treatment period and an optional open-label extension (OLE) period. OLE period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label semorinemab treatment.

Participant milestones

Participant milestones
Measure	Placebo Double Blind Period Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
Overall Study STARTED	135	94	136	92
Overall Study COMPLETED	1	0	2	0
Overall Study NOT COMPLETED	134	94	134	92

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Double Blind Period Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
Overall Study Caregiver Unavailability	1	1	0	0
Overall Study Research Department Closure	0	0	1	0
Overall Study Caregiver and Participant Withdrew Consent	0	0	1	0
Overall Study Medical Monitor Decision	1	0	0	0
Overall Study Participant Non-Compliance	0	0	1	0
Overall Study Drug Interrupted for Too Long Due to Prohibited Med	0	0	1	0
Overall Study Participant Non Compliance With Concomitant Medications	0	0	1	0
Overall Study Caregiver Passed Away	1	0	0	0
Overall Study Physician Decision	0	2	2	2
Overall Study Protocol Deviation	2	1	3	1
Overall Study Study Terminated By Sponsor	101	75	100	69
Overall Study Withdrawal by Subject	14	6	14	12
Overall Study Adverse Event	10	7	6	5
Overall Study Death	2	0	2	1
Overall Study Lost to Follow-up	2	1	1	0
Overall Study Participant No Longer Has Study Partner	0	0	0	1
Overall Study Withdrawal by Caregiver	0	1	0	0
Overall Study Caregiver Passed Away & Family Moved Out of State	0	0	1	0
Overall Study Absence of Consistent and Reliable Caregiver	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Double Blind Period n=135 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=94 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=136 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=92 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Total n=457 Participants Total of all reporting groups
Age, Continuous	69.7 Year STANDARD_DEVIATION 7.3 • n=5 Participants	70.2 Year STANDARD_DEVIATION 6.7 • n=7 Participants	69.3 Year STANDARD_DEVIATION 7.1 • n=5 Participants	69.6 Year STANDARD_DEVIATION 6.7 • n=4 Participants	69.6 Year STANDARD_DEVIATION 6.9 • n=21 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	51 Participants n=7 Participants	79 Participants n=5 Participants	48 Participants n=4 Participants	253 Participants n=21 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	43 Participants n=7 Participants	57 Participants n=5 Participants	44 Participants n=4 Participants	204 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants n=5 Participants	80 Participants n=7 Participants	125 Participants n=5 Participants	79 Participants n=4 Participants	410 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	83 Participants n=7 Participants	128 Participants n=5 Participants	82 Participants n=4 Participants	422 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 73 Weeks

Population: Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=105 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=77 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=113 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=74 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the CDR-SB	2.19 Units on a scale Standard Error 0.226	2.36 Units on a scale Standard Error 0.268	2.36 Units on a scale Standard Error 0.222	2.41 Units on a scale Standard Error 0.27	—

PRIMARY outcome

Timeframe: Up to the data cutoff date 15 January 2021 (up to approximately 39 months)

Population: The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.

Percentage of participants with at least one adverse event

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=130 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=89 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=132 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=90 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period n=360 Participants Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Percentage of Participants With Adverse Events	93.1 Percentage of participants	88.8 Percentage of participants	94.7 Percentage of participants	92.2 Percentage of participants	47.5 Percentage of participants

PRIMARY outcome

Timeframe: Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)

Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=130 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=89 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=132 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=90 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period n=360 Participants Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the C-SSRS SI3/SI1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI3/SI2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI3/SI3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS Missing/No Events	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Change From Baseline on the C-SSRS Missing/SI1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS Missing/SI2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS Missing/SI3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS Missing/SI4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS Missing/Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS No Event/No Event	119 Participants	80 Participants	123 Participants	83 Participants	336 Participants
Change From Baseline on the C-SSRS No Event/SI1	3 Participants	3 Participants	2 Participants	4 Participants	5 Participants
Change From Baseline on the C-SSRS No Event/ SI2	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Change From Baseline on the C-SSRS No Event/SI3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS No Event/ SI4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS No Event/ Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline on the C-SSRS SI1/No Event	3 Participants	3 Participants	1 Participants	1 Participants	8 Participants
Change From Baseline on the C-SSRS SI1/SI1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the C-SSRS SI1/SI2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI1/SI3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI1/SI4	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI1/Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI2/No Event	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Change From Baseline on the C-SSRS SI2/SI1	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Change From Baseline on the C-SSRS SI2/SI2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline on the C-SSRS SI2/SI3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI2/SI4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI2/Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI3/No Event	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the C-SSRS SI3/SI4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI3/Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI4/No Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI4/SI1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI4/SI2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the C-SSRS SI4/SI3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the C-SSRS SI4/Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89

Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=135 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=94 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=136 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=92 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period n=360 Participants Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Other Abnormal MRI Findings CNS Trauma, Week 73	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Intracranial Tumor, Week 73	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Lacunar Infarct, Week 73	0 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Superficial Hemosiderosis, Week 73	0 Number of participants	1 Number of participants	0 Number of participants	1 Number of participants	—
Other Abnormal MRI Findings Territorial Infarct, Week 73	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Week 73	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Cerebrovascular Pathology, Study Treatment Early Discontinuation	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings CSN Trauma, Study Treatment Early Discontinuation	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Intracranial Tumor, Study Treatment Early Discontinuation	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Lucunar Infarct, Study Treatment Early Discontinuation	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Superficial Hemosiderosis, Study Treatment Early Discontinuation	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Territorial Infarct, Study Treatment Early Discontinuation	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Study Treatment Early Discontinuation	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Cerebrovascular Pathology, Week 89 Open Label Extension (OLE)	—	—	—	—	0 Number of participants
Other Abnormal MRI Findings CNS Trauma, Week 89 OLE	—	—	—	—	0 Number of participants
Other Abnormal MRI Findings Intracranial Tumor, Week 89 OLE	—	—	—	—	1 Number of participants
Other Abnormal MRI Findings Lacunar Infarct, Week 89 OLE	—	—	—	—	0 Number of participants
Other Abnormal MRI Findings Superficial Hemosiderosis, Week 89 OLE	—	—	—	—	0 Number of participants
Other Abnormal MRI Findings Territorial Infarct, Week 89 OLE	—	—	—	—	0 Number of participants
Other Abnormal MRI Findings Cerebrovascular Pathology, Baseline	3 Number of participants	0 Number of participants	2 Number of participants	1 Number of participants	5 Number of participants
Other Abnormal MRI Findings CNS Trauma, Baseline	0 Number of participants	0 Number of participants	0 Number of participants	1 Number of participants	1 Number of participants
Other Abnormal MRI Findings Intracranial Tumor, Baseline	0 Number of participants	0 Number of participants	3 Number of participants	2 Number of participants	4 Number of participants
Other Abnormal MRI Findings Lacunar Infarct, Baseline	13 Number of participants	3 Number of participants	11 Number of participants	6 Number of participants	23 Number of participants
Other Abnormal MRI Findings Superficial Hemosiderosis, Baseline	3 Number of participants	0 Number of participants	2 Number of participants	0 Number of participants	7 Number of participants
Other Abnormal MRI Findings Territorial Infarct, Baseline	3 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants	4 Number of participants
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Baseline	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants
Other Abnormal MRI Findings Cerebrovascular Pathology, Week 9	0 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings CNS Trauma, Week 9	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Intracranial Tumor, Week 9	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Lacunar Infarct, Week 9	0 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Superficial Hemosiderosis, Week 9	3 Number of participants	0 Number of participants	0 Number of participants	1 Number of participants	—
Other Abnormal MRI Findings Territorial Infarct, Week 9	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Week 9	0 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Cerebrovascular Pathology, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings CNS Trauma, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Intracranial Tumor, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Lacunar Infarct, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Superficial Hemosiderosis, Week 49	1 Number of participants	1 Number of participants	1 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Territorial Infarct, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Week 49	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Cerebrovascular Pathology, Week 73	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	—
Other Abnormal MRI Findings Vasogenic Edema/Sulcal Effusion, Week 89 OLE	—	—	—	—	1 Number of participants

SECONDARY outcome

Timeframe: Baseline and 73 weeks

The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=87 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=62 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=93 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=63 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)	-5.53 Score on a scale Standard Error 0.787	-5.25 Score on a scale Standard Error 0.93	-4.62 Score on a scale Standard Error 0.765	-6.15 Score on a scale Standard Error 0.926	—

SECONDARY outcome

Timeframe: Baseline and 73 weeks

The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=94 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=67 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=97 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=66 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score	6.56 Score on a scale Standard Error 0.777	8.68 Score on a scale Standard Error 0.937	6 Score on a scale Standard Error 0.769	7.58 Score on a scale Standard Error 0.932	—

SECONDARY outcome

Timeframe: Baseline and 73 weeks

The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=95 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=70 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=109 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=67 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire	-6.59 Score on a scale Standard Error 0.856	-6.55 Score on a scale Standard Error 0.999	-6.92 Score on a scale Standard Error 0.824	-7.31 Score on a scale Standard Error 1.013	—

SECONDARY outcome

Timeframe: Baseline and 73 weeks

The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=104 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=76 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=112 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=74 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory	-8.55 Score on a scale Standard Error 0.996	-9.52 Score on a scale Standard Error 1.179	-7.75 Score on a scale Standard Error 0.986	-7.99 Score on a scale Standard Error 1.183	—

SECONDARY outcome

Timeframe: Up to 109 weeks

Population: The PK-evaluable population is defined as patients who received Semorinemab treatment and had at least one measureable PK concentration.

Serum concentrations of Semorinemab at specified timepoints.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=89 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=132 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=90 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Serum Concentrations of Semorinemab at Specified Timepoints Week 1, 0-4 Hours Predose	NA ug/mL Standard Deviation NA Not reportable. Below the level of detection.	NA ug/mL Standard Deviation NA Not reportable. Below the level of detection.	NA ug/mL Standard Deviation NA Not reportable. Below the level of detection.	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 1, 1 Hour Postdose	472 ug/mL Standard Deviation 131	1580 ug/mL Standard Deviation 496	2690 ug/mL Standard Deviation 689	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 1, 2 Hours Postdose	476 ug/mL Standard Deviation 123	1510 ug/mL Standard Deviation 419	2600 ug/mL Standard Deviation 707	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 1, 4 Hours postdose	463 ug/mL Standard Deviation 135	1370 ug/mL Standard Deviation 405	2570 ug/mL Standard Deviation 785	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 3, 0-4 hours Predose	184 ug/mL Standard Deviation 52.7	601 ug/mL Standard Deviation 211	1100 ug/mL Standard Deviation 449	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 3, 30 min Post dose	718 ug/mL Standard Deviation 198	2320 ug/mL Standard Deviation 581	4190 ug/mL Standard Deviation 1010	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 5, 0-4 Hours Predose	318 ug/mL Standard Deviation 81.5	955 ug/mL Standard Deviation 256	1920 ug/mL Standard Deviation 614	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 5, 30 min Postdose	908 ug/mL Standard Deviation 508	2780 ug/mL Standard Deviation 695	4860 ug/mL Standard Deviation 1250	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 9, 0-4 hours Predose	344 ug/mL Standard Deviation 128	961 ug/mL Standard Deviation 288	1840 ug/mL Standard Deviation 513	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 9, 30 Minutes Postdose	889 ug/mL Standard Deviation 321	2790 ug/mL Standard Deviation 757	4960 ug/mL Standard Deviation 1270	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 13, 0-4 Hours Predose	360 ug/mL Standard Deviation 105	1060 ug/mL Standard Deviation 333	1910 ug/mL Standard Deviation 545	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 13, 30 Minutes Postdose	998 ug/mL Standard Deviation 896	2900 ug/mL Standard Deviation 668	4880 ug/mL Standard Deviation 1250	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 17	—	—	1750 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 17, 0-4 Hours Predose	386 ug/mL Standard Deviation 116	1040 ug/mL Standard Deviation 316	1890 ug/mL Standard Deviation 522	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 17, 30 Minutes Postdose	819 ug/mL Standard Deviation 242	2930 ug/mL Standard Deviation 902	4770 ug/mL Standard Deviation 1270	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 33, 0-4 Hours Predose	404 ug/mL Standard Deviation 134	960 ug/mL Standard Deviation 277	2050 ug/mL Standard Deviation 648	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 33, 30 Minutes Postdose	801 ug/mL Standard Deviation 260	2540 ug/mL Standard Deviation 853	4800 ug/mL Standard Deviation 1200	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 49, 0-4 Hours Predose	377 ug/mL Standard Deviation 105	1060 ug/mL Standard Deviation 332	2160 ug/mL Standard Deviation 605	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 49, 30 Minutes Postdose	871 ug/mL Standard Deviation 260	2810 ug/mL Standard Deviation 967	4960 ug/mL Standard Deviation 1030	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 65	—	—	2100 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 65, 0-4 Hours Predose	405 ug/mL Standard Deviation 127	1170 ug/mL Standard Deviation 276	2020 ug/mL Standard Deviation 681	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 65, 30 Minutes Postdose	963 ug/mL Standard Deviation 401	2930 ug/mL Standard Deviation 830	4710 ug/mL Standard Deviation 1450	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 73	327 ug/mL Standard Deviation 154	1030 ug/mL Standard Deviation 451	1830 ug/mL Standard Deviation 752	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 73, 0-4 Hours Predose	—	382 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 73, 1 Hour Postdose	—	1910 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 73, 2 Hours Postdose	—	1740 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 73, 4 Hours Postdose	—	1710 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 77 OLE, 0-4 Hours Predose	180 ug/mL Standard Deviation 71.0	724 ug/mL Standard Deviation 167	1030 ug/mL Standard Deviation 345	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 77 OLE, 1 hour Postdose	1700 ug/mL Standard Deviation 523	2460 ug/mL Standard Deviation 868	2670 ug/mL Standard Deviation 707	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 77 OLE, 2 hours Postdose	1830 ug/mL Standard Deviation 552	2270 ug/mL Standard Deviation 442	2510 ug/mL Standard Deviation 579	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 77 OLE, 4 hours Postdose	1850 ug/mL Standard Deviation 516	2270 ug/mL Standard Deviation 480	2790 ug/mL Standard Deviation 558	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 93 OLE, 0-4 Hours Pre-dose	632 ug/mL Standard Deviation 37.5	1040 ug/mL Standard Deviation 113	1290 ug/mL Standard Deviation 307	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 93 OLE, 30 Minutes Postdose	1920 ug/mL Standard Deviation 431	2570 ug/mL Standard Deviation 91.9	2880 ug/mL Standard Deviation 492	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 109 OLE, 0-4 Hours Predose	—	1270 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—
Serum Concentrations of Semorinemab at Specified Timepoints Week 109 OLE, 30 Minutes Postdose	—	3330 ug/mL Standard Deviation NA Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.	—	—	—

SECONDARY outcome

Timeframe: Up to 109 weeks

Population: The immunogenicity analyses will include participants with at least one predose and one postdose ADA assessment, with participants grouped according to treatment arm.

Presence of anti-drug antibodies during the study relative to their presence at baseline.

Outcome measures

Outcome measures
Measure	Placebo Double Blind Period n=130 Participants Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=89 Participants Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=132 Participants Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=90 Participants Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label Extension Period Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline Post-baseline	—	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—

Adverse Events

Placebo Double Blind Period

Serious events: 14 serious events

Other events: 76 other events

Deaths: 2 deaths

Dose 1 Semorinemab Double Blind Period

Serious events: 17 serious events

Other events: 57 other events

Deaths: 0 deaths

Dose 2 Semorinemab Double Blind Period

Serious events: 17 serious events

Other events: 88 other events

Deaths: 1 deaths

Dose 3 Semorinemab Double Blind Period

Serious events: 16 serious events

Other events: 60 other events

Deaths: 1 deaths

Dose 2 Semorinemab Open Label

Serious events: 17 serious events

Other events: 76 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Double Blind Period n=130 participants at risk Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=89 participants at risk Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=132 participants at risk Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=90 participants at risk Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label n=360 participants at risk Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Blood and lymphatic system disorders Anaemia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Angina unstable	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Atrial fibrillation	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Atrioventricular block	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Bradycardia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Cardiac arrest	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Coronary artery disease	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Myocardial infarction	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Sinus node dysfunction	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Cardiac disorders Ventricular fibrillation	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Eye disorders Retinal detachment	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Enteritis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Haemorrhoids	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Inguinal hernia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Large intestine perforation	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Pancreatitis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Rectal polyp	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
General disorders Chest pain	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
General disorders Euthanasia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
General disorders Sudden death	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Hepatobiliary disorders Bile duct stone	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations COVID-19	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Clostridium difficile colitis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Diverticulitis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Parainfluenzae virus infection	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Peritonsillar abscess	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Pneumonia	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	3.3% 3/90 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Septic shock	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Tooth abscess	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Urinary tract infection	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Face injury	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Fall	1.5% 2/130 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Femoral neck fracture	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Femur fracture	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.5% 2/132 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Road traffic accident	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Skin wound	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Investigations Blood pressure increased	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Metabolism and nutrition disorders Dehydration	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Amnesia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Cluster headache	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Coma	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Encephalopathy	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Ischaemic stroke	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Post-traumatic headache	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Sciatica	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Syncope	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.5% 2/132 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Toxic encephalopathy	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Aggression	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Agitation	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.2% 2/90 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Confusional state	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Delirium	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Major depression	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Mental status changes	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Paranoia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Persecutory delusion	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/90 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Suicide attempt	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Renal and urinary disorders Calculus urinary	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.77% 1/130 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/132 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Tonsillar cyst	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/360 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/89 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.76% 1/132 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.

Other adverse events

Other adverse events
Measure	Placebo Double Blind Period n=130 participants at risk Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.	Dose 1 Semorinemab Double Blind Period n=89 participants at risk Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.	Dose 2 Semorinemab Double Blind Period n=132 participants at risk Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.	Dose 3 Semorinemab Double Blind Period n=90 participants at risk Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.	Dose 2 Semorinemab Open Label n=360 participants at risk Semorinemab was administered intravenously at dose 2 in the open-label extension period.
Gastrointestinal disorders Diarrhoea	3.1% 4/130 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/89 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	7.6% 10/132 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.4% 4/90 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.4% 5/360 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Gastrointestinal disorders Nausea	0.00% 0/130 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	10.1% 9/89 • Number of events 9 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.1% 8/132 • Number of events 9 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.4% 4/90 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.83% 3/360 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
General disorders Fatigue	1.5% 2/130 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	3.0% 4/132 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Nasopharyngitis	8.5% 11/130 • Number of events 15 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/89 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	13.6% 18/132 • Number of events 24 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	13.3% 12/90 • Number of events 14 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.56% 2/360 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Upper respiratory tract infection	11.5% 15/130 • Number of events 21 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/89 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.3% 7/132 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 4/360 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Infections and infestations Urinary tract infection	7.7% 10/130 • Number of events 13 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.5% 4/89 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	7.6% 10/132 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.8% 10/360 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Fall	16.9% 22/130 • Number of events 26 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	15.7% 14/89 • Number of events 15 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	16.7% 22/132 • Number of events 33 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	7.8% 7/90 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.0% 18/360 • Number of events 21 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Infusion related reaction	4.6% 6/130 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	11.2% 10/89 • Number of events 16 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	8.3% 11/132 • Number of events 15 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/90 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.4% 5/360 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Injury, poisoning and procedural complications Skin laceration	3.1% 4/130 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/89 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.5% 2/132 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.00% 0/90 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.4% 5/360 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Investigations Blood pressure increased	1.5% 2/130 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 1/89 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.1% 8/132 • Number of events 12 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.2% 2/90 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.83% 3/360 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 8/130 • Number of events 10 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/89 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	7.6% 10/132 • Number of events 12 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	8.9% 8/90 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.2% 8/360 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	6.2% 8/130 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/89 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.1% 8/132 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/90 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.4% 5/360 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Dizziness	9.2% 12/130 • Number of events 12 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/89 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.5% 6/132 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	7.8% 7/90 • Number of events 9 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 4/360 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Nervous system disorders Headache	7.7% 10/130 • Number of events 13 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.2% 2/89 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.1% 8/132 • Number of events 11 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/90 • Number of events 9 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.2% 15/360 • Number of events 15 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Anxiety	2.3% 3/130 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	11.2% 10/89 • Number of events 10 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.5% 6/132 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/90 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.28% 1/360 • Number of events 1 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Depression	3.8% 5/130 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/89 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.3% 7/132 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.83% 3/360 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Psychiatric disorders Insomnia	2.3% 3/130 • Number of events 3 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	2.2% 2/89 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	3.0% 4/132 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	0.56% 2/360 • Number of events 2 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 4/130 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	6.7% 6/89 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.3% 7/132 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 8 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.4% 5/360 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.
Vascular disorders Hypertension	5.4% 7/130 • Number of events 7 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	4.5% 4/89 • Number of events 4 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	10.6% 14/132 • Number of events 14 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	5.6% 5/90 • Number of events 6 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.	1.1% 4/360 • Number of events 5 • From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months) The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER