Neurotoxicity in patients treated with crotoxin
Dose (mg/m2) | Days of treatment | Neurotoxicitya grade (study days) | ||||||
---|---|---|---|---|---|---|---|---|
Diplopiab | Palpebral ptosis | Nystagmus | Anxiety | |||||
0.18 | 30 | 2 (9–19) | — | — | — | |||
0.18 | 30 | 2 (6–14) | ||||||
0.18 | 30 | 2 (2–10) | ||||||
0.21 | 30 | 2 (2–20) | ||||||
0.21 | 30 | 2 (1–14) | ||||||
0.21 | 90 | 2 (11–21) | ||||||
0.22 | 30 | 2 (2–4) | (19–22) | 2 (15–16) | 2 (15), 3 (16) | |||
0.22 | 90 | 2 (6–14) | — | 2 (16–17) | 3 (17) | |||
0.22 | 30 | 2 (8) | — | — | — | |||
0.22 | 30 | 2 (4, 5) | ||||||
0.22 | 30 | 2 (2–21) | (18–20) | 2 (15) | 3 (15) | |||
0.22 | 30 | 2 (8–21) | (12–18) | 2 (19–20) | 2 (19); 3 (20) | |||
0.21 | 2 | Died on study day 3c | ||||||
0.21 | 90 | 2 (2–21) | ||||||
0.21 | 60 | 2 (2–11) | ||||||
0.21 | 90 | 2 (1–5) | ||||||
0.21 | 30 | 2 (10–21) | Discharged on study day 31d | |||||
0.21 | 8 | 2 (4–5) | Abandoned protocol on day 8e |
a No neural toxicity was observed at doses up to 0.18 mg/m2.
b Diplopia appeared intermittently within the study days indicated in parenthesis.
c This patient died on study day 3 of pulmonary edema.
d Patient had a mild allergic reaction on study day 3 and a grade 3 anaphylactic reaction on day 31.
e Patient abandoned the protocol on study day 8, unable to adapt to the obligatory in-patient condition required by this study.