Table 5.
Adverse events with suspected study drug relationship (incidence > 10%) by preferred term.
| Everolimus | ||
|---|---|---|
| N=40 | ||
| All Grades | Grade ≥3 | |
| Preferred term | n (%) | n (%) |
| Number of patients with at least one event | 39 (97.5) | 11 (27.5) |
| Stomatitis | 17 (42.5) | 2 (5.0) |
| Mouth ulceration | 15 (37.5) | 1 (2.5) |
| Blood triglycerides increased | 11 (27.5) | 1 (2.5) |
| Blood cholesterol increased | 10 (25.0) | 0 |
| Hypercholesterolaemia | 10 (25.0) | 0 |
| Hypertriglyceridaemia | 10 (25.0) | 2 (5.0) |
| Blood lactate dehydrogenase increased | 8 (20.0) | 0 |
| Protein urine present | 8 (20.0) | 3 (7.5) |
| Alanine aminotransferase increased | 7 (17.5) | 0 |
| Anaemia | 6 (15.0) | 1 (2.5) |
| Blood creatinine increased | 6 (15.0) | 0 |
| Menstruation delayed | 6 (15.0) | 0 |
| Weight decreased | 6 (15.0) | 0 |
| White blood cell count decreased | 6 (15.0) | 0 |
| Aspartate aminotransferase increased | 5 (12.5) | 0 |
| Dermatitis acneiform | 5 (12.5) | 0 |
| Folliculitis | 5 (12.5) | 0 |
| Menstrual disorder | 5 (12.5) | 0 |
| Neutrophil count decreased | 4 (10.0) | 0 |
| Pneumonia | 4 (10.0) | 0 |
| Proteinuria | 4 (10.0) | 2 (5.0) |
-Numbers (n) represent counts of patients.
-A patient with multiple severity grades for an AE is only counted under the maximum grade.
MedDRA version 23.0, CTCAE version 4.03.