Table 6.
Types of ADRs | Number (%) |
---|---|
General disorders and administration site conditions | 26 (0.69) |
Asthenia | 2 (0.05) |
Chest pain | 1 (0.03) |
Death | 2 (0.05) |
Feeling abnormal | 4 (0.11) |
Gait disturbance | 1 (0.03) |
Malaise | 9 (0.24) |
Multiorgan failure | 1 (0.03) |
Sudden death | 2 (0.05) |
Thirst | 4 (0.11) |
Investigations | 21 (0.56) |
Alanine aminotransferase increased | 3 (0.08) |
Aspartate aminotransferase increased | 3 (0.08) |
Blood lactate dehydrogenase increased | 1 (0.03) |
Blood parathyroid hormone increased | 1 (0.03) |
Blood prolactin increased | 2 (0.05) |
Blood triglycerides increased | 1 (0.03) |
Electrocardiogram T-wave amplitude decreased | 1 (0.03) |
Eosinophil count increased | 1 (0.03) |
Gamma-glutamyltransferase increased | 5 (0.13) |
Hemoglobin decreased | 2 (0.05) |
Liver function test abnormal | 2 (0.05) |
Platelet count decreased | 1 (0.03) |
White blood cell count decreased | 1 (0.03) |
Zinc sulfate turbidity increased | 1 (0.03) |
Bone density decreased | 1 (0.03) |
Blood phosphorus increased | 1 (0.03) |
Thymol turbidity test increased | 1 (0.03) |
Triiodothyronine free decreased | 1 (0.03) |
Thyroxine free increased | 1 (0.03) |
Blood alkaline phosphatase increased | 4 (0.11) |
Injury, poisoning, and procedural complications | 11 (0.29) |
Ankle fracture | 1 (0.03) |
Fall | 1 (0.03) |
Femur fracture | 1 (0.03) |
Head injury | 1 (0.03) |
Shunt occlusion | 1 (0.03) |
Spinal compression fracture | 2 (0.05) |
Subdural hematoma | 1 (0.03) |
Brain contusion | 1 (0.03) |
Shunt malfunction | 1 (0.03) |
Procedural hypotension | 3 (0.08) |
Notes: ADRs are coded with the preferred terms of MedDRA/J (version 18.1). The figure beside each category of disease shows the number (%) of patients with the type of ADR, while the number of each ADR shows the number of incidents (in parentheses, the number of incidents over the total number of patients researched).
Abbreviation: ADRs, adverse drug reactions.