A Phase 2 Study to Evaluate Safety of Long-term AL001 Dos... | NCT03987295

Name	Class
GlaxoSmithKline	INDUSTRY

Label	Type	Description	Intervention Names
Granulin and C9orf72	Experimental	IV administration of AL001; 60 mg/kg, every 4 weeks [q4w]	Drug: AL001

Name	Type	Description	Arm Group Labels	Other Names
AL001	Drug	60 mg/kg of AL001 every 4 weeks	Granulin and C9orf72

Measure	Description	Time Frame
Severity of TEAEs	Number of TEAEs categorized by severity	197 weeks
Severity of Treatment-Related TEAEs	Number of treatment-related TEAEs categorized by severity	197 weeks
Any TEAE Leading to Study Drug Discontinuation	Number of TEAEs leading to study drug discontinuation	197 weeks
Immunogenicity Antidrug Antibodies (ADA) Titer	Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study	97 weeks
Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses	Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).	97 weeks
Change From Baseline in Sheehan Suicidality Tracking Scale	The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.

Measure	Description	Time Frame
Longitudinal Percent Change From Baseline of CSF PGRN	The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.	97 weeks
Longitudinal Percent Change From Baseline in Plasma PGRN

Name	Affiliation	Role
Peter Ljubenkov, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCSF		San Francisco	California	94158	United States
Mayo Clinic

ID	Title	Description
FG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 4, 2021	Jun 5, 2025

ID	Title	Description
BG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
BG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
BG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG00112 BG00216 BG00333

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Severity of TEAEs

Number of TEAEs categorized by severity

There is no statistical analysis for this primary end point.

Posted

Number

TEAEs (all)

197 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Units	Counts
Participants	OG0005 OG00112 OG00216

Title

Denominators

Categories

Mild

Title	Measurements
	OG00043 OG00158 OG00284

Moderate

Primary

Severity of Treatment-Related TEAEs

Number of treatment-related TEAEs categorized by severity

There is no statistical analysis for this primary end point.

Posted

Number

TEAEs (treatment-related)

197 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Primary

Any TEAE Leading to Study Drug Discontinuation

Number of TEAEs leading to study drug discontinuation

There is no statistical analysis for this primary end point.

Posted

Number

TEAE leading to discontinuation

197 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Primary

Immunogenicity Antidrug Antibodies (ADA) Titer

Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study

There is no statistical analysis for this primary end point.

Posted

Median

Full Range

Titers

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Primary

Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses

Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).

Posted

Count of Participants

Participants

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Primary

Change From Baseline in Sheehan Suicidality Tracking Scale

The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.

There is no statistical analysis for this primary endpoint.

Posted

Mean

Standard Deviation

Scores

197 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Longitudinal Percent Change From Baseline of CSF PGRN

The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.

There is no statistical analysis for this secondary end point.

Posted

Mean

Standard Deviation

percent change of ug/L

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Longitudinal Percent Change From Baseline in Plasma PGRN

The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.

There is no statistical analysis for this secondary end point.

Posted

Mean

Standard Deviation

percent change in ug/L

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Longitudinal Levels of Sortilin in WBCs

The overall change from baseline in Sortilin in WBCs.

WBC samples for analysis for Sortilin expression were collected to serve as a pharmacodynamic biomarker of target engagement. Development of this assay found that stability of these samples was not reliable for accurate measurement. Hence, we did not measure Sortilin in this study.

Posted

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Latozinemab Concentration in Serum

Serum concentration of Latozinemab at week 97.

There is no statistical analysis for this secondary end point.

Posted

Mean

Standard Deviation

ng/mL

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Cmax of Latozinemab at Specified Timepoints

Maximum observed concentration of Latozinemab at week 96 of treatment.

There is no statistical analysis for this secondary end point.

Posted

Mean

Standard Deviation

ug/mL

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

Ctrough of Latozinemab at Specified Timepoints

Trough concentration of Latozinemab at week 96 of treatment

There is no statistical analysis for this secondary endpoint.

Posted

Mean

Standard Deviation

ug/mL

97 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Secondary

ARCmax of Latozinemab

Ratio of latozinemab Cmax at week 61 to the Cmax at week 1

There is no statistical analysis for this endpoint.

Posted

Mean

Standard Deviation

Ratio

61 weeks

ID	Title	Description
OG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).
OG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Diastolic hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Administration site extravasation	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Crying	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Influenza like illness	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Infusion site extravasation	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Infusion site pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Infusion site paraesthesia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Seasonal allergy	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Actinic keratosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected12 at risk EG0021 events1 affected16 at risk
Depression	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Illusion	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Impulsive behavior	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Insomnia	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected12 at risk EG0020 events0 affected16 at risk
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Paranoia	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Restlessness	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Sleep disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Device physical property issue	Product Issues	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Blood cholesterol increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Blood potassium increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Hepatic enzyme increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Lipase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Weight decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected5 at risk EG0015 events5 affected12 at risk EG0027 events7 affected16 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected12 at risk EG0020 events0 affected16 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Weight increased	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0021 events1 affected16 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Aphasia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected12 at risk EG0022 events2 affected16 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Lacunar infarction	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Lacunar stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Myoclonus	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Parkinsonian rest tremor	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Polyneuropathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Seizure like phenomena	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Subdural hygroma	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected12 at risk EG0021 events1 affected16 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Blepharitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Dry eye	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Episcleritis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Lacrimation increased	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Retinal detachment	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Vision blurred	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected12 at risk EG0021 events1 affected16 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Toothache	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0022 events2 affected16 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Pseudofolliculitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected12 at risk EG0021 events1 affected16 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Nocturia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected12 at risk EG0020 events0 affected16 at risk
Urge incontinence	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Urinary retention	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Goitre	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Medial tibial stress syndrome	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Acute sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected12 at risk EG0025 events5 affected16 at risk
Cellulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Ear infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Eye infection bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Folliculitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Herpes simplex	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Hordeolum	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Lyme disease	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Onychomycosis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Otitis externa	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Skin infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Tooth infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0021 events1 affected16 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0012 events2 affected12 at risk EG0026 events6 affected16 at risk
Viral rhinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk
Eye contusion	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0021 events1 affected16 at risk
Gout	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk

ID	Term
D057174	Frontotemporal Lobar Degeneration
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D057177	TDP-43 Proteinopathies
D019636	Neurodegenerative Diseases
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	aFTD-GRN	aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).	0	5	1	5	4	5
EG001	FTD-GRN	FTD-GRN - symptomatic carriers of GRN mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).	0	12	3	12	9	12
EG002	FTD-C9orf72	FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks [q4w]), for a total of 25 doses (96-week dosing period).	1	16	2	16	13	16

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected12 at risk EG0020 events0 affected16 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0023 events2 affected16 at risk
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected12 at risk EG0020 events0 affected16 at risk
Aggression	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected12 at risk EG0021 events1 affected16 at risk