Table 4 Serious adverse events and serious adverse drug reactions classified by systemic organ class according to the World Health Organization Adverse Reaction Terminology
Systemic organ class and preferred terma | Total (N = 209) | |||
|---|---|---|---|---|
SAEs | SADRs | |||
Number of Subjects (%) | Number of Events | Number of Subjects (%) | Number of Events | |
Total | 16 (7.66) | 28 | 6 (2.87) | 9 |
Resistance mechanism disorders | 6 (2.87) | 7 | 3 (1.44) | 3 |
Pneumonia | 2 (0.96) | 2 | 1 (0.48) | 1 |
Cystitis | 1 (0.48) | 1 | 0 (0.00) | 0 |
Infection susceptibility increased | 1 (0.48) | 1 | 1 (0.48) | 1 |
Abscess | 1 (0.48) | 1 | 0 (0.00) | 0 |
Herpes zoster | 1 (0.48) | 1 | 1 (0.48) | 1 |
Polyomavirus infection | 1 (0.48) | 1 | 0 (0.00) | 0 |
Gastro-intestinal system disorders | 3 (1.44) | 4 | 2 (0.96) | 2 |
Diarrhea | 2 (0.96) | 2 | 2 (0.96) | 2 |
Ileus | 1 (0.48) | 2 | 0 (0.00) | 0 |
Urinary system disorders | 5 (2.39) | 5 | 3 (1.44) | 3 |
Azotemia | 4 (1.91) | 4 | 3 (1.44) | 3 |
Urinary tract disorder | 1 (0.48) | 1 | 0 (0.00) | 0 |
Skin and appendages disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Dermatitis contact | 1 (0.48) | 1 | 0 (0.00) | 0 |
Metabolic and nutritional disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Plasma osmolality increased | 1 (0.48) | 1 | 0 (0.00) | 0 |
Body as a whole– general disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Ascites | 1 (0.48) | 1 | 0 (0.00) | 0 |
Liver and biliary system disorders | 1 (0.48) | 1 | 1 (0.48) | 1 |
Cholangitis | 1 (0.48) | 1 | 1 (0.48) | 1 |
Musculo-skeletal system disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Fracture | 1 (0.48) | 1 | 0 (0.00) | 0 |
Secondary terms – events | 2 (0.96) | 2 | 0 (0.00) | 0 |
Transplant rejection | 2 (0.96) | 2 | 0 (0.00) | 0 |
Respiratory system disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Dyspnea | 1 (0.48) | 1 | 0 (0.00) | 0 |
White cell and RES disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Granulocyopenia | 1 (0.48) | 1 | 0 (0.00) | 0 |
Endocrine disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Hyperparathyroidism | 1 (0.48) | 1 | 0 (0.00) | 0 |
Myo-, endo-, pericardial & valve disorders | 1 (0.48) | 1 | 0 (0.00) | 0 |
Angina pectoris aggravated | 1 (0.48) | 1 | 0 (0.00) | 0 |
Cardiovascular disorders, general | 1 (0.48) | 1 | 0 (0.00) | 0 |
Hypertension | 1 (0.48) | 1 | 0 (0.00) | 0 |