Table 1.
ADRs of Debio1143 with more than one occurrence, by System Organ Class and Preferred Term (PT)
| Dose cohort | 100 mg (N=8) | 200 mg (N=12) | 300 mg (N=4) | 400 mg (N=5) | AE, total 441 (100%) | Pts, total 29 (100%) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System Organ Class / • PT | Pts | AE | Pts | AE | Pts | AE | Pts | AE | AE | % | Pts | % |
| Blood / lymphatic system | 2 | 2 | 1 | 1 | 3 | 1 | 3 | 2 | 9 | 2.0 | 6 | 20.7 |
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| •Febrile neutropenia | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 6 | 1.4 | 4 | 13.8 |
| •Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 0.5 | 1 | 3.4 |
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| Cardiac disorders | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 | 0.5 | 2 | 6.9 |
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| Eye disorders | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0.5 | 1 | 3.4 |
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| Gastrointestinal disorders | 12 | 7 | 11 | 4 | 3 | 1 | 0 | 0 | 26 | 5.9 | 12 | 41.4 |
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| •Diarrhoea | 3 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 4 | 0.9 | 4 | 13.8 |
| •Nausea | 5 | 5 | 4 | 4 | 0 | 0 | 0 | 0 | 9 | 2.0 | 9 | 31.0 |
| •Stomatitis | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 0.5 | 2 | 6.9 |
| •Vomiting | 2 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 0.7 | 3 | 10.3 |
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| General / admin. site | 4 | 3 | 5 | 4 | 1 | 1 | 0 | 0 | 10 | 2.3 | 8 | 27.6 |
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| •Fatigue | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 3 | 0.7 | 3 | 10.3 |
| •Mucosal inflammation | 1 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 3 | 0.7 | 3 | 10.3 |
| •Pyrexia | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 3 | 0.7 | 2 | 6.9 |
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| Infections / infestations | 1 | 1 | 2 | 2 | 1 | 1 | 2 | 1 | 6 | 1.4 | 5 | 17.2 |
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| Investigations | 5 | 3 | 2 | 2 | 3 | 1 | 3 | 1 | 13 | 2.9 | 7 | 24.1 |
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| •ALT increased | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 0.7 | 3 | 10.3 |
| •AST increased | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 0.7 | 2 | 6.9 |
| •Blood bilirubin increased | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 0.5 | 2 | 6.9 |
| •ECG QT prolonged | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 3 | 0.7 | 1 | 3.4 |
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| Metabolism / nutrition | 0 | 0 | 5 | 3 | 1 | 1 | 7 | 1 | 13 | 2.9 | 5 | 17.2 |
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| •Decreased appetite | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 0.5 | 2 | 6.9 |
| •Hypocalcaemia | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 3 | 0.7 | 1 | 3.4 |
| •Hypokalaemia | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 1 | 4 | 0.9 | 2 | 6.9 |
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| Nervous system disorders | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0.5 | 2 | 6.9 |
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| Respiratory, thoracic mediastinal disorders | 2 | 1 | 3 | 3 | 3 | 1 | 0 | 0 | 8 | 1.8 | 5 | 17.2 |
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| Skin, subcutaneous tissue | 2 | 2 | 3 | 2 | 0 | 0 | 0 | 0 | 5 | 1.1 | 4 | 13.8 |
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| Total ADRs | 8 | 32 | 7 | 33 | 2 | 15 | 2 | 16 | 96 | 21.8 | 19 | 65.5 |
Pts: patients