Table 4.
Gastrointestinal toxicities by initial dose level
| Dose Cohort N |
80 n=4 |
100 n=7 |
120 n=3 |
140 n=8 |
160 n=12 |
Total n=34 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| AE | Grade | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 |
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| Diarrhea | 2 | 1 | 5 | 2 | 3 | 0 | 6 | 0 | 11 | 1 | 27 | 4 | |
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| Nausea | 3 | 0 | 5 | 0 | 3 | 0 | 4 | 0 | 9 | 0 | 24 | 0 | |
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| Dyspepsia | 0 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 5 | 0 | 10 | 0 | |
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| Vomiting | 2 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 8 | 0 | |
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| Anorexia | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 3 | 1 | 6 | 3 | |
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| Dysgeusia | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | |
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| Constipation | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | |
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| Dysphagia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | |
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| Flatulence | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | |
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| Gastritis | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | |
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| Hemorrhoids | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | |
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| Mucositisoral | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | |