Table 3. Adverse events record during study.
| |
Grade |
Relationship to study drug |
|||||
|---|---|---|---|---|---|---|---|
| AE category | 1 | 2 | 3 | Probable | Possible | Unlikely | Unrelated |
| Pyrexia |
1 |
3 |
|
|
|
3 |
1 |
| Fatigue |
12 |
8 |
9 |
2 |
12 |
8 |
7 |
| Nausea and vomiting |
48 |
6 |
1 |
13 |
27 |
14 |
1 |
| Diarrhoea |
3 |
|
|
|
|
3 |
|
| Headache |
4 |
|
|
2 |
1 |
1 |
|
| Oedema |
3 |
3 |
|
|
|
5 |
1 |
| Cough; shortness of breath |
4 |
3 |
3 |
|
|
3 |
7 |
| Skin – injection site reaction |
5 |
|
|
|
3 |
2 |
|
| Anorexia |
3 |
6 |
2 |
|
3 |
6 |
2 |
| Myalgia |
2 |
|
|
|
1 |
1 |
|
| Constipation |
7 |
2 |
1 |
|
|
8 |
2 |
| Elevated alkaline phosphatase/bili |
|
1 |
1 |
|
|
|
2 |
| Alopecia |
1 |
|
|
|
|
1 |
|
| Ocular |
3 |
1 |
|
|
|
3 |
1 |
| Hyperkalemia |
1 |
|
|
|
|
1 |
|
| Hypertension – transient |
4 |
|
|
3 |
1 |
|
|
| Hypoalbuminemia |
1 |
5 |
|
|
2 |
2 |
2 |
| Hypoglycemia |
2 |
1 |
|
|
2 |
1 |
|
| Hypokalemia |
2 |
|
1 |
|
|
1 |
2 |
| Hyponatremia |
1 |
|
|
|
|
1 |
|
| Bacteremia |
|
|
1 |
|
|
1 |
|
| Coagulation – prolonged INR |
|
1 |
1 |
|
2 |
|
|
| Hypotension – transient |
|
1 |
2 |
|
|
1 |
2 |
| Other GI |
2 |
1 |
|
|
|
3 |
|
| Dizziness |
9 |
|
|
1 |
7 |
1 |
|
| Pain |
5 |
8 |
8 |
|
|
4 |
17 |
| Other metabolic |
2 |
|
1 |
|
|
2 |
1 |
| Urinary |
2 |
2 |
|
|
|
3 |
1 |
| Cardiac – transient |
|
1 |
|
|
|
|
1 |
| Leucopenia |
3 |
|
|
|
|
3 |
|
| Platelets |
6 |
|
|
|
|
6 |
|
| Vascular: deep vein thrombosis |
|
|
1 |
|
|
|
1 |
| Anaemia |
12 |
11 |
5 |
|
5 |
21 |
2 |
| Dehydration |
|
1 |
|
|
|
|
1 |
| Oral |
4 |
|
|
|
2 |
2 |
|
|
Totals |
152 |
65 |
37 |
21 |
68 |
111 |
54 |
| Percentage | 60% | 26% | 15% | 8% | 27% | 44% | 21% |
Abbreviations: AE=adverse event; GI=gastrointestinal; INR=international normalized ratio.
The AEs listed here are all those reported during all courses of treatment and for each visit. For this reason, the total number of AEs is much higher than the number of subjects (15) enrolled in the study. Very often, the higher frequency AEs represent recurring episodes in the same subject and reflect conditions already existing when the patient entered the study. The treating physician did not consider any of these adverse events directly related to p28 administration.