Table 6 Most common drug-related adverse events in the integrated safety analysis and CANTAM
Primary system class and preferred term | Integrated safety analysis | CANTAM PA (N = 2599) | |||||
|---|---|---|---|---|---|---|---|
PA (N = 667) | AL (N = 358) | P valuea | |||||
N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | ||
Vomiting | 32 | 4.8 (3.4, 6.7) | 11 | 3.1 (1.7, 5.4) | 0.25 | 109 | 4.2 (3.5, 5.0) |
Blood glucose decreased | 25 | 3.7 (2.6, 5.5) | 12 | 3.4 (1.9, 5.8) | 0.86 | 0 | 0 (0, 0.1) |
Platelet count increased | 25 | 3.7 (2.6, 5.5) | 13 | 3.6 (2.1, 6.1) | 1.0 | 0 | 0 (0, 0.1) |
AST increased | 21 | 3.1 (2.1, 4.8) | 15 | 4.2 (2.6, 6.8) | 0.38 | 0 | 0 (0, 0.1) |
ECG QT prolonged | 20 | 3.0 (1.9, 4.6) | 28 | 7.8 (5.5, 11.1) | 0.0009 | 0 | 0 (0, 0.1) |
Anaemia | 16 | 2.4 (1.5, 3.9) | 13 | 3.6 (2.1, 6.1) | 0.32 | 4 | 0.2 (0.1, 0.4) |
Blood albumin decreased | 15 | 2.2 (1.4, 3.7) | 14 | 3.9 (2.3, 6.5) | 0.17 | 0 | 0 (0, 0.1) |
Neutropenia | 15 | 2.2 (1.4, 3.7) | 8 | 2.2 (1.1, 4.3) | 1.0 | 0 | 0 (0, 0.1) |
ALT increased | 14 | 2.1 (1.3, 3.5) | 6 | 1.7 (0.8, 3.6) | 0.81 | 0 | 0 (0, 0.1) |
Blood potassium increased | 14 | 2.1 (1.3, 3.5) | 4 | 1.1 (0.4, 2.8) | 0.32 | 0 | 0 (0, 0.1) |
Haemoglobin decreased | 13 | 1.9 (1.1, 3.3) | 5 | 1.4 (0.6, 3.2) | 0.62 | 1 | 0.04 (0.002, 0.2) |
Haematocrit decreased | 12 | 1.8 (1.0, 3.1) | 4 | 1.1 (0.4, 2.8) | 0.60 | 0 | 0 (0, 0.1) |
Upper RTI | 11 | 1.6 (0.9, 2.9) | 4 | 1.1 (0.4, 2.8) | 0.59 | 0 | 0 (0, 0.1) |
Monocytosis | 8 | 1.2 (0.6, 2.3) | 9 | 2.5 (1.3, 4.7) | 0.13 | 0 | 0 (0, 0.1) |
WBC increased | 8 | 1.2 (0.6, 2.3) | 1 | 0.3 (0.014, 1.6) | 0.17 | 0 | 0 (0, 0.1) |
Bronchitis | 7 | 1.0 (0.5, 2.2) | 11 | 3.1 (1.7, 5.4) | 0.02 | 0 | 0 (0, 0.1) |
Abdominal pain | 6 | 0.9 (0.4, 1.9) | 4 | 1.1 (0.4, 2.8) | 0.75 | 7 | 0.3 (0.1, 0.6) |
Blood creatinine decreased | 5 | 0.7 (0.3, 1.7) | 6 | 1.7 (0.8, 3.6) | 0.21 | 0 | 0 (0, 0.1) |
Rhinitis | 3 | 0.4 (0.1, 1.3) | 4 | 1.1 (0.4, 2.8) | 0.25 | 0 | 0 (0, 0.1) |
Pyrexia | 1 | 0.1 (0.008, 0.8) | 0 | 0 (0, 1.1) | 1.0 | 25 | 1.0 (0.7, 1.4) |