A Study of Different Donanemab (LY3002813) Dosing Regimen... | NCT05738486

NCT05738486

ID	Type	Description
I5T-MC-AACQ	Other Identifier	Eli Lilly and Company
2022-502268-18-00	Other Identifier	EU Trial Number
U1111-1285-9438	Other Identifier	UTN Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1400 mg Donanemab - Standard Regimen	Experimental	Participants received: 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose	Drug: Donanemab Drug: Placebo
1400 mg Donanemab - Dose Skipping	Experimental	Participants received: 700 mg donanemab administered IV at baseline. placebo administered IV at week 2, 4, 6, 10, and 14. 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose	Drug: Donanemab Drug: Placebo
1400 mg Donanemab - Titration	Experimental	Participants received: 350 mg donanemab administered IV at baseline. placebo administered IV at week 2, 6, 10, and 14. 700 mg donanemab administered IV at week 4. 1050 mg of donanemab administered IV at week 8. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose	Drug: Donanemab Drug: Placebo
1400 mg Donanemab - Maximum Concentration (Cmax)	Experimental	Participants received: 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. 700 mg donanemab administered IV at weeks 12 and 14. 1400 mg of donanemab administered IV at weeks 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donanemab	Drug	Administered IV	1400 mg Donanemab - Dose Skipping 1400 mg Donanemab - Maximum Concentration (Cmax) 1400 mg Donanemab - Standard Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)	Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.	24 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Any Occurrence of ARIA-E	Outcome data will be provided after the study is completed.	52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MD First Research - Chandler		Chandler	Arizona	85286	United States
Irvine Clinical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40619285	Derived	Wang H, Nery ESM, Ardayfio P, Khanna R, Svaldi DO, Shcherbinin S, Xu W, Andersen SW, Hauck PM, Brooks DA, Collins EC, Salloway S, Mintun MA, Sims JR. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. 2025 Sep;12(8):100266. doi: 10.1016/j.tjpad.2025.100266. Epub 2025 Jul 5.
40172303

Label	URL
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	1400 mg Donanemab - Standard Regimen	Participants received: 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
FG001	1400 mg Donanemab - Dose Skipping

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 26, 2023	May 16, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

1400 mg Donanemab - Titration

Donanemab Addendum 2 Arm 1

Donanemab Addendum 2 Arm 2

Outcome data will be provided after the study is completed.

All participants who received at least one dose of donanemab.

Arm/Group Information

ID	Title	Description
BG000	1400 mg Donanemab - Standard Regimen	Participants received: 700 mg donanemab administered IV at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
BG001	1400 mg Donanemab - Dose Skipping	Participants received: 700 mg donanemab administered IV at baseline. placebo administered IV at week 2, 4, 6, 10, and 14. 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
BG002	1400 mg Donanemab - Titration	Participants received: 350 mg donanemab administered IV at baseline. placebo administered IV at week 2, 6, 10, and 14. 700 mg donanemab administered IV at week 4. 1050 mg of donanemab administered IV at week 8. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
BG003	1400 mg Donanemab - Cmax	Participants received: 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. 700 mg donanemab administered IV at weeks 12 and 14. 1400 mg of donanemab administered IV at weeks 16, 20, and 24.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00073.30± 5.66 BG00173.40± 5.80 BG00274.30± 5.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000120 BG001117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United Kingdom

Title	Measurements
	BG00020 BG00128 BG002

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

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.

All participants who received at least one dose of donanemab and had evaluable data for this outcome.

Posted

Number

Percentage of participants

24 Weeks

ID	Title	Description
OG000	1400 mg Donanemab - Standard Regimen	Participants received: 700 mg donanemab administered IV at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
OG001	1400 mg Donanemab - Dose Skipping	Participants received: 700 mg donanemab administered IV at baseline. placebo administered IV at week 2, 4, 6, 10, and 14. 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
OG002	1400 mg Donanemab - Titration	Participants received: 350 mg donanemab administered IV at baseline. placebo administered IV at week 2, 6, 10, and 14. 700 mg donanemab administered IV at week 4. 1050 mg of donanemab administered IV at week 8. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
OG003	1400 mg Donanemab - Cmax	Participants received: 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. 700 mg donanemab administered IV at weeks 12 and 14. 1400 mg of donanemab administered IV at weeks 16, 20, and 24.

Units	Counts
Participants	OG000207 OG001210 OG002212 OG003

Title

Denominators

Categories

Title	Measurements
	OG00023.67 OG00118.57 OG00213.68 OG003

Secondary

Percentage of Participants With Any Occurrence of ARIA-E

Outcome data will be provided after the study is completed.

Not Posted

May 2026

52 Weeks

Participants

Secondary

Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan

Outcome data will be provided after the study is completed.

Not Posted

May 2026

Baseline, 76 Weeks

Participants

Secondary

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)

Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.

All participants who received at least one dose of donanemab and had evaluable data for this outcome.

Posted

Number

Percentage of participants

24 Weeks

ID	Title	Description
OG000	1400 mg Donanemab - Standard Regimen	Participants received: 700 mg donanemab administered IV at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
OG001	1400 mg Donanemab - Dose Skipping	Participants received: 700 mg donanemab administered IV at baseline. placebo administered IV at week 2, 4, 6, 10, and 14. 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
OG002	1400 mg Donanemab - Titration	Participants received: 350 mg donanemab administered IV at baseline. placebo administered IV at week 2, 6, 10, and 14. 700 mg donanemab administered IV at week 4. 1050 mg of donanemab administered IV at week 8. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.

Secondary

Percentage of Participants With ARIA-H

Outcome data will be provided after the study is completed.

Not Posted

May 2026

52 Weeks

Participants

Secondary

Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H

Outcome data will be provided after the study is completed.

Not Posted

May 2026

76 Weeks

Participants

Secondary

Pharmacokinetics (PK): Average Serum Concentration of Donanemab

Outcome data will be provided after the study is completed.

Not Posted

May 2026

Baseline to 76 Weeks

Participants

Secondary

Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies

Outcome data will be provided after the study is completed.

Not Posted

May 2026

Baseline to End of Follow-Up (91 Weeks)

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1400 mg Donanemab - Standard Regimen	Participants received: 700 mg donanemab administered IV at baseline, week 4, and 8. placebo administered IV at week 2, 6, 10, and 14. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.	0	207	18	207	139	207
EG001	1400 mg Donanemab - Dose Skipping	Participants received: 700 mg donanemab administered IV at baseline. placebo administered IV at week 2, 4, 6, 10, and 14. 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.	0	210	18	210	140	210
EG002	1400 mg Donanemab - Titration	Participants received: 350 mg donanemab administered IV at baseline. placebo administered IV at week 2, 6, 10, and 14. 700 mg donanemab administered IV at week 4. 1050 mg of donanemab administered IV at week 8. 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.	1	212	23	212	141	212
EG003	1400 mg Donanemab - Cmax	Participants received: 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. 700 mg donanemab administered IV at weeks 12 and 14. 1400 mg of donanemab administered IV at weeks 16, 20, and 24.	0	213	20	213	137	213

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG0031 events1 affected213 at risk
Bradycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Laryngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0022 events1 affected212 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0021 events1 affected212 at risk EG003
Urosepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0022 events2 affected212 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0022 events2 affected212 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0012 events2 affected210 at risk EG0020 events0 affected212 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0023 events1 affected212 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Middle cerebral artery stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0004 events2 affected207 at risk EG0010 events0 affected210 at risk EG0022 events2 affected212 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0021 events1 affected212 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Tracheomalacia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Axillary vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected210 at risk EG0021 events1 affected212 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00015 events12 affected207 at risk EG00112 events12 affected210 at risk EG0028 events6 affected212 at risk EG00315 events15 affected213 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG00019 events11 affected207 at risk EG0018 events8 affected210 at risk EG00214 events12 affected212 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00010 events10 affected207 at risk EG00116 events16 affected210 at risk EG00219 events19 affected212 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0009 events8 affected207 at risk EG00114 events14 affected210 at risk EG0028 events8 affected212 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0007 events7 affected207 at risk EG00123 events18 affected210 at risk EG00219 events16 affected212 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG00026 events16 affected207 at risk EG00121 events17 affected210 at risk EG00220 events19 affected212 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG00042 events27 affected207 at risk EG00127 events18 affected210 at risk EG00269 events34 affected212 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0009 events8 affected207 at risk EG0016 events5 affected210 at risk EG00214 events13 affected212 at risk EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00038 events33 affected207 at risk EG00140 events33 affected210 at risk EG00232 events28 affected212 at risk EG003
Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00058 events49 affected207 at risk EG00140 events38 affected210 at risk EG00232 events29 affected212 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00020 events19 affected207 at risk EG00118 events16 affected210 at risk EG00217 events17 affected212 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00088 events41 affected207 at risk EG00154 events44 affected210 at risk EG00242 events32 affected212 at risk EG003
Superficial siderosis of central nervous system	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00014 events12 affected207 at risk EG00120 events13 affected210 at risk EG0026 events5 affected212 at risk EG003

First MCP Posted Date

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
C000729112	donanemab
D003907	Dexamethasone

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated