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%) |
N number of patients treated within the group, n (%) number and % of patients with at least one AE in each category.