Table 2 List of adverse events lead to discontinuation of Rapamune
Systemic organ class and preferred terma | Total (N = 209) | |
|---|---|---|
Number of Subjects (%) | Number of Adverse Events | |
Resistance mechanism disorders | ||
Infection susceptibility increased | 1 (0.48) | 1 |
Polyomavirus infection | 1 (0.48) | 1 |
Gastro-intestinal system disorders | ||
Diarrhoea | 5 (2.39) | 5 |
Stomatitis | 3 (1.44) | 3 |
Stomatitis ulcerative | 1 (0.48) | 1 |
Abdominal pain | 2 (0.96) | 2 |
Nausea | 1 (0.48) | 1 |
Urinary system disorders | ||
Azotaemia | 6 (2.87) | 6 |
Albuminuria | 1 (0.48) | 1 |
Oliguria | 1 (0.48) | 1 |
Skin and appendages disorders | ||
Acne | 1 (0.48) | 1 |
Rash | 1 (0.48) | 1 |
Rash erythematous | 2 (0.96) | 2 |
Dermatitis | 1 (0.48) | 1 |
Metabolic and nutritional disorders | ||
Diabetes mellitus | 1 (0.48) | 1 |
Diabetes mellitus aggravated | 1 (0.48) | 1 |
Plasma osmolality increased | 1 (0.48) | 1 |
Body as a whole– general disorders | ||
Edema peripheral | 1 (0.48) | 1 |
Face edema | 2 (0.96) | 2 |
Anaphylactic reaction | 1 (0.48) | 1 |
Liver and biliary system disorders | ||
Hepatic function abnormal | 1 (0.48) | 1 |
Cholangitis | 1 (0.48) | 1 |
Musculo-skeletal system disorders | ||
Avascular necrosis bone | 1 (0.48) | 1 |
Secondary terms – events | ||
Transplant rejection | 2 (0.96) | 2 |
Respiratory system disorders | ||
Coughing (≥ 4 weeks) | 1 (0.48) | 1 |
White cell and RES disorders | ||
Leucopenia | 1 (0.48) | 1 |