Table 3.
Classification, frequency, severity and causality of recorded adverse events during 32 days of BP-C1 or placebo treatment
| Treatment | AE classification | Severity
|
Causality
|
|||
|---|---|---|---|---|---|---|
| Mild | Moderate | Possible | Probable | Definite | ||
| BP-C1 | Abnormal weight gain | 1 | 1 | |||
| Administration site pain | 1 | 1 | ||||
| Blood glucose increased | 1 | 1 | ||||
| Lactate dehydrogenase | 1 | 1 | 2 | |||
| increased | ||||||
| Constipation | 1 | 1 | ||||
| Decreased appetite | 1 | 1 | ||||
| Dizziness | 1 | 1 | ||||
| Dysgeusia | 1 | 1 | ||||
| Fatigue | 1 | 1 | ||||
| Flushing | 1 | 1 | ||||
| Headache | 1 | 1 | 1 | 1 | ||
| Hyperhidrosis | 1 | 1 | ||||
| Hypertension | 1 | 1 | ||||
| Lethargy | 1 | 1 | ||||
| Nausea | 3 | 1 | 2 | |||
| Vomiting | 1 | 1 | ||||
| Sum | 16 | 4 | 6 | 13 | 1 | |
| Placebo | Dyspepsia | 1 | 1 | |||
| Hematuria | 1 | 1 | ||||
| Hypophosphatemia | 1 | 1 | ||||
| Hypoalbuminemia | 1 | 1 | ||||
| Protein urine present | 1 | 1 | ||||
| Proteinuria | 1 | 1 | ||||
| Sum | 6 | 0 | 0 | 5 | 1 | |
Note: Results are expressed as number of adverse events.
Abbreviations: AE, adverse event; BP-C1, benzene-poly-carboxylic acids complex with cis-diammineplatium (II) dichloride.