Table 3—

Summary of adverse events at 6 months in randomly assigned and exposed patients

Treatment-emergent adverse events occurring with an incidence of ≥2% in the rimonabant treatment group listed by preferred term*Placebo20 mg rimonabant
n140138
Any adverse event81 (57.9)97 (70.3)
    Dizziness3 (2.1)15 (10.9)
    Nausea5 (3.6)12 (8.7)
    Nasopharyngitis11 (7.9)10 (7.2)
    Upper respiratory tract infection3 (2.1)10 (7.2)
    Anxiety5 (3.6)8 (5.8)
    Depressed mood1 (0.7)8 (5.8)
    Diarrhea6 (4.3)6 (4.3)
    Vertigo1 (0.7)6 (4.3)
    Vomiting1 (0.7)6 (4.3)
    Asthenia1 (0.7)5 (3.6)
    Headache9 (6.4)5 (3.6)
    Anorexia04 (2.9)
    Back pain4 (2.9)4 (2.9)
    Fall3 (2.1)4 (2.9)
    Fatigue1 (0.7)4 (2.9)
    Paresthesia2 (1.4)4 (2.9)
    Sinusitis2 (1.4)4 (2.9)
    Vision blurred04 (2.9)
    Arthralgia4 (2.9)3 (2.2)
    Dry mouth03 (2.2)
    Hypoesthesia03 (2.2)
    Influenza2 (1.4)3 (2.2)
    Insomnia3 (2.1)3 (2.2)
    Pain1 (0.7)3 (2.2)
    Shoulder pain1 (0.7)3 (2.2)
    Somnolence03 (2.2)
    Visual acuity reduced03 (2.2)
Adverse events leading to permanent study discontinuation
    Overall dropout rate15 (10.7)27 (19.6)
    Any serious adverse event5 (3.6)9 (6.5)
    Discontinuation due to any adverse event3 (2.1)13 (9.4)
    Psychiatric disorders
Any psychiatric adverse event07 (5.1)
Depressed mood03 (2.2)
    Nervous system disorders
Any nervous system adverse event05 (3.6)
Paresthesia03 (2.2)
Dizziness02 (1.4)
Hyposmia02 (1.4)
    Gastrointestinal disorders
Any gastrointestinal system adverse event1 (0.7)4 (2.9)
    Metabolism and nutrition disorders
Any adverse event related to metabolism or nutrition02 (1.4)
Anorexia02 (1.4)
  • Data are n (%). One patient can report several events.

  • *

    * Defined according to the MedDRA classification.

  • One patient died (during treatment with placebo) as a result of a subdural hemorrhage due to a meningioma.

  • According to MedDRA, at least two patients in any rimonabant group and only in main system organ classes (1%).