Table 1 Adverse events (AE).
Primary system organ class Preferred term [n (%)] | SAR425899 (N = 13) |
|---|---|
Any class | 12 (92.3%) |
Infections and infestations | 1 (7.7%) |
Pyelonephritis | 1 (7.7%) |
Metabolism and nutrition disorders | 7 (53.8%) |
Decreased appetite | 7 (53.8%) |
Psychiatric disorders | 1 (7.7%) |
Anxiety | 1 (7.7%) |
Nervous system disorders | 4 (30.8%) |
Headache | 3 (23.1%) |
Dizziness postural | 1 (7.7%) |
Presyncope | 1 (7.7%) |
Respiratory, thoracic and mediastinal disorders | 2 (15.4%) |
Hiccups | 1 (7.7%) |
Oropharyngeal pain | 1 (7.7%) |
Gastrointestinal disorders | 10 (76.9%) |
Nausea | 7 (53.8%) |
Eructation | 3 (23.1%) |
Constipation | 2 (15.4%) |
Dyspepsia | 2 (15.4%) |
Gastritis | 2 (15.4%) |
Vomiting | 2 (15.4%) |
Abdominal pain | 1 (7.7%) |
Diarrhoea | 1 (7.7%) |
Dry mouth | 1 (7.7%) |
Gastrointestinal disorder | 1 (7.7%) |
Musculoskeletal and connective tissue disorders | 1 (7.7%) |
Arthralgia | 1 (7.7%) |
General disorders and administration site conditions | 8 (61.5%) |
Fatigue | 4 (30.8%) |
Malaise | 2 (15.4%) |
Asthenia | 1 (7.7%) |
Discomfort | 1 (7.7%) |
Early satiety | 1 (7.7%) |
Investigations | 1 (7.7%) |
Lipase increased | 1 (7.7%) |
