Participants with Severe Adverse Events
(Incidence ≥ 0% in One or More Treatment Groups)
(ASaT Population)


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
(Incidence ≥ 0% in One or More Treatment Groups)
(ASaT Population)


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
(Incidence ≥ 0% in One or More Treatment Groups)
(ASaT Population)


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]