Participants
with Severe Adverse Events |
|||
|
Placebo |
Xanomeline Low Dose |
Xanomeline High Dose |
|
n |
n |
n |
Participants in population |
86 |
84 |
84 |
with one or more severe AE |
7 |
16 |
8 |
with no severe AE |
79 |
68 |
76 |
|
|
|
|
cardiac disorders |
3 |
0 |
1 |
atrial fibrillation |
0 |
0 |
1 |
atrioventricular block second degree |
1 |
0 |
0 |
myocardial infarction |
2 |
0 |
0 |
gastrointestinal disorders |
0 |
0 |
2 |
gastrointestinal haemorrhage |
0 |
0 |
1 |
nausea |
0 |
0 |
1 |
general disorders and administration site conditions |
0 |
7 |
0 |
application site dermatitis |
0 |
1 |
0 |
application site erythema |
0 |
2 |
0 |
application site irritation |
0 |
3 |
0 |
application site pruritus |
0 |
1 |
0 |
application site warmth |
0 |
1 |
0 |
|
|||
Participants
with Severe Adverse Events |
|||
|
Placebo |
Xanomeline Low Dose |
Xanomeline High Dose |
|
n |
n |
n |
general disorders and administration site conditions |
0 |
7 |
0 |
sudden death |
0 |
1 |
0 |
infections and infestations |
0 |
1 |
0 |
nasopharyngitis |
0 |
1 |
0 |
injury, poisoning and procedural complications |
1 |
0 |
1 |
hip fracture |
1 |
0 |
1 |
musculoskeletal and connective tissue disorders |
1 |
1 |
0 |
arthritis |
1 |
0 |
0 |
muscle spasms |
0 |
1 |
0 |
neoplasms benign, malignant and unspecified (incl cysts and polyps) |
0 |
1 |
1 |
colon cancer |
0 |
1 |
0 |
prostate cancer |
0 |
0 |
1 |
nervous system disorders |
0 |
3 |
4 |
dizziness |
0 |
0 |
1 |
headache |
0 |
1 |
0 |
partial seizures with secondary generalisation |
0 |
0 |
1 |
stupor |
0 |
1 |
0 |
syncope |
0 |
2 |
1 |
transient ischaemic attack |
0 |
1 |
1 |
|
|||
Participants
with Severe Adverse Events |
|||
|
Placebo |
Xanomeline Low Dose |
Xanomeline High Dose |
|
n |
n |
n |
psychiatric disorders |
1 |
1 |
0 |
agitation |
0 |
1 |
0 |
completed suicide |
1 |
0 |
0 |
reproductive system and breast disorders |
1 |
0 |
0 |
benign prostatic hyperplasia |
1 |
0 |
0 |
skin and subcutaneous tissue disorders |
0 |
4 |
1 |
blister |
0 |
1 |
0 |
pruritus |
0 |
1 |
0 |
rash |
0 |
1 |
1 |
skin irritation |
0 |
1 |
0 |
This is footnote |
|||
Source: [Study MK9999P001: adam-adae] |