Table 2. Summary of toxicities (days 0–4) according to CTC 2 over all courses.
| Toxicity per course | Toxicity according to dose level / courses | Toxicity per patient | |||||
|---|---|---|---|---|---|---|---|
|
Symptom |
Toxicity/ total courses |
Percent courses with toxicity (all) |
Dose level 1 10mg/m2 |
Dose level 2 20mg/m2 |
Dose level 3 30mg/m2 |
Toxicity/ total patients |
Percent patients with toxicity |
|
Fever |
31/41 |
76% |
5/7 |
17/25 |
9/9 |
15/16 |
94% |
|
Elevated C-reactive proteins |
20/41 |
49% |
2/7 |
12/25 |
6/9 |
8/16 |
50% |
|
Acute Allergic Reaction |
18/41 |
44% |
0/7 |
12/25 |
6/9 |
7/16 |
44% |
|
Symptoms of serum sickness |
0/41 |
0% |
0/7 |
0/25 |
0/9 |
0/16 |
0% |
|
Ocular symptoms |
0/41 |
0% |
0/7 |
0/25 |
0/9 |
0/16 |
0% |
|
Hypertension |
0/40 |
0% |
0/7 |
0/24 |
0/9 |
0/16 |
0% |
|
Pain despite analgesic therapy |
12/41 |
29% |
1/7 |
8/25 |
3/9 |
10/16 |
63% |
|
Urine retention |
14/41 |
34% |
1/7 |
10/25 |
3/9 |
8/16 |
50% |
|
Constipation |
21/41 |
51% |
2/7 |
14/25 |
5/9 |
8/16 |
50% |
|
Diarrhea |
3/41 |
7% |
0/7 |
1/25 |
2/9 |
3/16 |
19% |
|
Nausea or Vomiting |
14/41 |
34% |
1/7 |
9/25 |
4/9 |
7/16 |
44% |
|
Bilirubin |
22/41 |
54% |
3/7 |
13/25 |
6/9 |
10/16 |
63% |
|
SGOT/SGPT |
26/41 |
63% |
4/7 |
16/25 |
6/9 |
14/16 |
88% |
|
Renal toxicity |
0/40 |
0% |
0/7 |
0/24 |
0/9 |
0/16 |
0% |
|
Leukopenia |
25/41 |
61% |
4/7 |
21/25 |
6/9 |
14/16 |
88% |
|
Thrombopenia |
17/41 |
42% |
2/7 |
11/25 |
4/9 |
10/16 |
44% |
|
Anaemia |
36/41 |
88% |
6/7 |
22/25 |
8/9 |
14/16 |
63% |
|
Neutropenia |
29/41 |
71% |
5/7 |
17/25 |
7/9 |
15/16 |
94% |
| Infection | 8/41 | 20% | 2/7 | 4/25 | 2/9 | 6/16 | 38% |
Legend: Toxicities listed are for grades 1–4.