Table 3.
Patients with Treatment-Emergent Adverse Events (TEAEs), n (%) | Safety Population (N = 47) |
Any TEAE | 21 (44.7) |
Any serious TEAE | 1 (2.1) |
TEAEs by MedDRA preferred term | |
Fall | 4 (8.5) |
Nausea | 3 (6.4) |
Diarrhea | 2 (4.3) |
Edema | 2 (4.3) |
Skin abrasion | 2 (4.3) |
Urinary tract infection | 2 (4.3) |
Abdominal pain | 1 (2.1) |
Abnormal dreams | 1 (2.1) |
Blood glucose increased | 1 (2.1) |
Blood pressure increased | 1 (2.1) |
Colitis | 1 (2.1) |
Constipation | 1 (2.1) |
Contusion | 1 (2.1) |
Dizziness | 1 (2.1) |
Gastritis | 1 (2.1) |
Gout | 1 (2.1) |
Hallucination, auditory | 1 (2.1) |
Hallucination, visual | 1 (2.1) |
Hypertonia | 1 (2.1) |
Hypothyroidism | 1 (2.1) |
Illusion | 1 (2.1) |
Insomnia | 1 (2.1) |
Laceration | 1 (2.1) |
Mental impairment | 1 (2.1) |
Muscle strain | 1 (2.1) |
Non-cardiac chest pain | 1 (2.1) |
Palpitations | 1 (2.1) |
Peripheral swelling | 1 (2.1) |
Presyncope | 1 (2.1) |
Rapid eye movement sleep behavior | 1 (2.1) |
disorder | |
Suicidal ideation | 1 (2.1) |
Supraventricular extrasystoles | 1 (2.1) |
Vomiting | 1 (2.1) |
MedDRA, Medical Dictionary for Regulatory Activities, Version 20.0.