Table 7 Recorded Adverse Events
System organ class MedDRA | Disease | Number of AE | % of all patients | % of all AE |
|---|---|---|---|---|
Total AE | 94 | 0.65 | 100.00 | |
N of patients who had at least 1 AE | 80 | 0.55 | ||
Skin and subcutaneous tissue disorders | Erythema | 1 | 0.007 | |
Pruritus | 6 | 0.04 | ||
Rash | 1 | 0.007 | ||
Urticaria | 2 | 0.01 | ||
N of AE in this group | 10 | 0.06 | 10.63 | |
N of patients who had at least 1 AE in this group | 8 | 0.05 | ||
Musculoskeletal and connective tissue disorders | Myalgia | 2 | 0.0139 | |
N of AE in this group | 2 | 0.0139 | 2.12 | |
N of patients who had at least 1 AE in this group | 2 | 0.0139 | ||
Nervous system disorders | Dizziness | 3 | 0.02 | |
Dysgeusia | 2 | 0.01 | ||
Head discomfort | 1 | 0.007 | ||
Headache | 11 | 0.07 | ||
N of AE in this group | 17 | 0.11 | 18.09 | |
N of patients who had at least 1 AE in this group | 15 | 0.10 | ||
Digestive system disorders | Abdominal distension | 2 | 0.01 | |
Abdominal pain | 14 | 0.09 | ||
Abdominal pain upper | 1 | 0.007 | ||
Anal pruritus | 1 | 0.007 | ||
Constipation | 4 | 0.02 | ||
Diarrhoea | 2 | 0.01 | ||
Dyschezia | 1 | 0.007 | ||
Dyspepsia | 1 | 0.007 | ||
Epigastric discomfort | 3 | 0.0209 | ||
Flatulence | 1 | 0.007 | ||
Nausea | 22 | 0.15 | ||
Tongue discomfort | 3 | 0.02 | ||
N of AE in this group | 55 | 0.38 | 58.51 | |
N of patients who had at least 1 AE in this group | 51 | 0.35 | ||
Cardiac disorders | Palpitations | 1 | 0.007 | |
N of AE in this group | 1 | 0.007 | 1.06 | |
N of patients who had at least 1 AE in this group | 1 | 0.007 | ||
General disorders and administration site conditions | Asthenia | 2 | 0.01 | |
Drug ineffective | 1 | 0.007 | ||
Feeling jittery | 1 | 0.007 | ||
N of AE in this group | 4 | 0.02 | 4.25 | |
N of patients who had at least 1 AE in this group | 3 | 0.02 | ||
Psychiatric disorders | Agitation | 2 | 0.01 | |
Sleep disorder | 1 | 0.007 | ||
N of AE in this group | 3 | 0.02 | 3.19 | |
N of patients who had at least 1 AE in this group | 2 | 0.01 | ||
Metabolism and nutrition disorders | Decreased appetite | 1 | 0.007 | |
Increased appetite | 1 | 0.007 | ||
N of AE in this group | 2 | 0.01 | 2.12 | |
N of patients who had at least 1 AE in this group | 2 | 0.01 |