Trial Outcomes & Findings for A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) (NCT NCT05738486)
NCT ID: NCT05738486
Last Updated: 2025-11-14
Results Overview
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1175 participants
Primary outcome timeframe
24 Weeks
Results posted on
2025-11-14
Participant Flow
Current results reporting is for primary results completion date (16-May-2024) i.e., up to week 24. Data beyond week 24 will be reported at the time of final results reporting.
Addendum recruited a separate cohort of participants than the main study (recruitment started on 14 July 2025). Data for the addendum arms will not be reported for Primary Outcome Measures. Participant Flow, Baseline Characteristics, and Adverse Events data for the addendum arms will be reported at the time of final results reporting.
Participant milestones
| Measure |
1400 mg Donanemab - Maximum Concentration (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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
213
|
208
|
210
|
212
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
213
|
207
|
210
|
212
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
213
|
208
|
210
|
212
|
Reasons for withdrawal
| Measure |
1400 mg Donanemab - Maximum Concentration (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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Continuing Study
|
191
|
194
|
196
|
193
|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
5
|
7
|
|
Overall Study
Adverse Event
|
5
|
4
|
6
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
2
|
|
Overall Study
Participant was Non-ambulatory
|
0
|
0
|
0
|
1
|
|
Overall Study
Participant had Poor Venous Access
|
1
|
0
|
0
|
0
|
|
Overall Study
Assigned Treatment by Mistake
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal Due to Caregiver Circumstances
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Baseline characteristics by cohort
| Measure |
1400 mg Donanemab - Standard Regimen
n=207 Participants
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.
|
1400 mg Donanemab - Dose Skipping
n=210 Participants
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.
|
1400 mg Donanemab - Titration
n=212 Participants
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.
|
1400 mg Donanemab - Cmax
n=213 Participants
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.
|
Total
n=842 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.30 years
STANDARD_DEVIATION 5.66 • n=10 Participants
|
73.40 years
STANDARD_DEVIATION 5.80 • n=10 Participants
|
74.30 years
STANDARD_DEVIATION 5.69 • n=20 Participants
|
73.20 years
STANDARD_DEVIATION 6.02 • n=45 Participants
|
73.60 years
STANDARD_DEVIATION 5.80 • n=44 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=10 Participants
|
117 Participants
n=10 Participants
|
126 Participants
n=20 Participants
|
123 Participants
n=45 Participants
|
486 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=10 Participants
|
93 Participants
n=10 Participants
|
86 Participants
n=20 Participants
|
90 Participants
n=45 Participants
|
356 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
15 Participants
n=45 Participants
|
46 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=10 Participants
|
193 Participants
n=10 Participants
|
195 Participants
n=20 Participants
|
190 Participants
n=45 Participants
|
767 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=45 Participants
|
29 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
9 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
13 Participants
n=45 Participants
|
46 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
196 Participants
n=10 Participants
|
197 Participants
n=10 Participants
|
193 Participants
n=20 Participants
|
196 Participants
n=45 Participants
|
782 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
4 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=10 Participants
|
28 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
27 Participants
n=45 Participants
|
95 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
187 Participants
n=10 Participants
|
182 Participants
n=10 Participants
|
192 Participants
n=20 Participants
|
186 Participants
n=45 Participants
|
747 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: All participants who received at least one dose of donanemab and had evaluable data for this outcome.
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
Outcome measures
| Measure |
1400 mg Donanemab - Standard Regimen
n=207 Participants
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.
|
1400 mg Donanemab - Dose Skipping
n=210 Participants
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.
|
1400 mg Donanemab - Titration
n=212 Participants
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.
|
1400 mg Donanemab - Cmax
n=213 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
|
23.67 Percentage of participants
|
18.57 Percentage of participants
|
13.68 Percentage of participants
|
18.31 Percentage of participants
|
SECONDARY outcome
Timeframe: 52 WeeksOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 76 WeeksOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 WeeksPopulation: All participants who received at least one dose of donanemab and had evaluable data for this outcome.
Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.
Outcome measures
| Measure |
1400 mg Donanemab - Standard Regimen
n=207 Participants
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.
|
1400 mg Donanemab - Dose Skipping
n=210 Participants
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.
|
1400 mg Donanemab - Titration
n=212 Participants
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.
|
1400 mg Donanemab - Cmax
n=213 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
|
25.12 Percentage of participants
|
22.86 Percentage of participants
|
20.28 Percentage of participants
|
20.66 Percentage of participants
|
SECONDARY outcome
Timeframe: 52 WeeksOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 76 WeeksOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 76 WeeksOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to End of Follow-Up (91 Weeks)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
Adverse Events
1400 mg Donanemab - Standard Regimen
Serious events: 18 serious events
Other events: 139 other events
Deaths: 0 deaths
1400 mg Donanemab - Dose Skipping
Serious events: 18 serious events
Other events: 140 other events
Deaths: 0 deaths
1400 mg Donanemab - Titration
Serious events: 23 serious events
Other events: 141 other events
Deaths: 1 deaths
1400 mg Donanemab - Cmax
Serious events: 20 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1400 mg Donanemab - Standard Regimen
n=207 participants at risk
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.
|
1400 mg Donanemab - Dose Skipping
n=210 participants at risk
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.
|
1400 mg Donanemab - Titration
n=212 participants at risk
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.
|
1400 mg Donanemab - Cmax
n=213 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Laryngitis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
General disorders
Chest pain
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Bronchitis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Cellulitis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Osteomyelitis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Pneumonia
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Sepsis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Urosepsis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.94%
2/212 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.94%
2/212 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.94%
2/213 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.95%
2/210 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 3 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Cerebral infarction
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Ischaemic stroke
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Seizure
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Syncope
|
0.97%
2/207 • Number of events 4 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.94%
2/212 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Psychiatric disorders
Mental status changes
|
0.48%
1/207 • Number of events 2 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Psychiatric disorders
Suicidal ideation
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Hypotension
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Aortic stenosis
|
0.48%
1/207 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Haematoma
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/213 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Hypertension
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.48%
1/210 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/212 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/207 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/210 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.47%
1/212 • Number of events 1 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
0.00%
0/213 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
Other adverse events
| Measure |
1400 mg Donanemab - Standard Regimen
n=207 participants at risk
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.
|
1400 mg Donanemab - Dose Skipping
n=210 participants at risk
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.
|
1400 mg Donanemab - Titration
n=212 participants at risk
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.
|
1400 mg Donanemab - Cmax
n=213 participants at risk
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.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.4%
7/207 • Number of events 7 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
8.6%
18/210 • Number of events 23 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
7.5%
16/212 • Number of events 19 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
4.2%
9/213 • Number of events 9 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
16/207 • Number of events 26 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
8.1%
17/210 • Number of events 21 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
9.0%
19/212 • Number of events 20 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
8.9%
19/213 • Number of events 23 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
12/207 • Number of events 15 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
5.7%
12/210 • Number of events 12 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
2.8%
6/212 • Number of events 8 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
7.0%
15/213 • Number of events 15 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
General disorders
Fatigue
|
5.3%
11/207 • Number of events 19 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
3.8%
8/210 • Number of events 8 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
5.7%
12/212 • Number of events 14 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
5.2%
11/213 • Number of events 12 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Covid-19
|
4.8%
10/207 • Number of events 10 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
7.6%
16/210 • Number of events 16 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
9.0%
19/212 • Number of events 19 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
5.6%
12/213 • Number of events 12 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
8/207 • Number of events 9 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
6.7%
14/210 • Number of events 14 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
3.8%
8/212 • Number of events 8 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
3.3%
7/213 • Number of events 8 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.0%
27/207 • Number of events 42 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
8.6%
18/210 • Number of events 27 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
16.0%
34/212 • Number of events 69 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
19.2%
41/213 • Number of events 86 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
8/207 • Number of events 9 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
2.4%
5/210 • Number of events 6 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
6.1%
13/212 • Number of events 14 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
1.9%
4/213 • Number of events 5 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
15.9%
33/207 • Number of events 38 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
15.7%
33/210 • Number of events 40 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
13.2%
28/212 • Number of events 32 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
17.4%
37/213 • Number of events 47 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
23.7%
49/207 • Number of events 58 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
18.1%
38/210 • Number of events 40 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
13.7%
29/212 • Number of events 32 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
18.3%
39/213 • Number of events 41 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Dizziness
|
9.2%
19/207 • Number of events 20 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
7.6%
16/210 • Number of events 18 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
8.0%
17/212 • Number of events 17 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
4.7%
10/213 • Number of events 13 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Headache
|
19.8%
41/207 • Number of events 88 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
21.0%
44/210 • Number of events 54 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
15.1%
32/212 • Number of events 42 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
15.5%
33/213 • Number of events 37 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
|
Nervous system disorders
Superficial siderosis of central nervous system
|
5.8%
12/207 • Number of events 14 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
6.2%
13/210 • Number of events 20 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
2.4%
5/212 • Number of events 6 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
1.9%
4/213 • Number of events 4 • Baseline Up To 24 Weeks
All participants who received at least one dose of donanemab. As pre-specified in statistical analysis plan, adverse events were reported per treatment arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60