Clinical Study

Perspectives of CB1 Antagonist in Treatment of Obesity: Experience of RIO-Asia

Table 4

Most common adverse events (≥2% in rimonabant-treated patients and ≥1% in placebo).

Placebo ( )Rimonabant (20 mg) ( )

Patients with any TEAE184 (56.8%)210 (66.0%)
Patients with any serious TEAE 15 (4.6%)10 (3.1%)
Patients with any TEAE leading to death 0 0
Patients permanently discontinued due to TEAE 9 (2.8%) 10 (3.1%)
Most common adverse events
Gastrointestinal disorders
Nausea 13 (4.0%) 37 (11.6%)
Diarrhea 14 (4.3%) 24 (7.5%)
Dyspepsia 2 (0.6%) 10 (3.1%)
Vomiting3 (0.9%)9 (2.8%)
Nervous system disorders
Dizziness 31 (9.6%) 34 (10.7%)
Psychiatric disorders
Insomnia 11 (3.4%) 14 (4.4%)
Depression 3 (0.9%) 13 (4.1%)
Anxiety5 (1.5%)12 (3.8%)
Skin and subcutaneous tissue disorders
Hyperhidrosis 3 (0.9%) 7 (2.2%)
Cardiac disorders
Palpitations 3 (0.9%) 15 (4.7%)
General disorders and administration site conditions
Fatigue 3 (0.9%) 8 (2.5%)
Infections and infestations
URTI29 (9.0%)34 (10.7%)

TEAE: treatment-emergent adverse event; URTI: upper respiratory tract infection.
Note: TEAEs included all adverse events with an onset date during treatment exposure and up to 75 days following the last study drug intake.