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) | ||
Bronchitis | 93 | 13.9 (11.5, 16.8) | 53 | 14.8 (11.5, 18.9) | 0.71 | 9 | 0.3 (0.2, 0.7) |
Vomiting | 52 | 7.8 (6.0, 10.1) | 12 | 3.4 (1.9, 5.8) | 0.004 | 141 | 5.4 (4.6, 6.4) |
Cough | 51 | 7.6 (5.9, 9.9) | 24 | 6.7 (4.5, 9.8) | 0.62 | 49 | 1.9 (1.4, 2.5) |
Rhinitis | 38 | 5.7 (4.2, 7.7) | 27 | 7.5 (5.2, 10.8) | 0.28 | 2 | 0.1 (0.01, 0.3) |
Anaemia | 35 | 5.2 (3.8, 7.2) | 17 | 4.7 (3.0, 7.5) | 0.77 | 20 | 0.8 (0.5, 1.2) |
Upper RTI | 34 | 5.1 (3.7, 7.0) | 12 | 3.4 (1.9, 5.8) | 0.21 | 0 | (0, 0.1) |
Platelet count increased | 30 | 4.5 (3.2, 6.3) | 17 | 4.7 (3.0, 7.5) | 0.88 | 0 | (0, 0.1) |
Blood glucose decreased | 27 | 4.0 (2.8, 5.8) | 15 | 4.2 (2.6, 6.8) | 1.00 | 0 | (0, 0.1) |
AST increased | 26 | 3.9 (2.7, 5.7) | 16 | 4.5 (2.8, 7.1) | 0.74 | 0 | (0, 0.1) |
ECG QT prolonged | 21 | 3.1 (2.1, 4.8) | 29 | 8.1 (5.7, 11.4) | 0.0007 | 0 | (0, 0.1) |
Pyrexia | 20 | 3.0 (1.9, 4.6) | 7 | 2.0 (1.0, 4.0) | 0.41 | 140 | 5.4 (4.6, 6.3) |
Influenza like illness | 17 | 2.5 (1.6, 4.0) | 4 | 1.1 (0.4, 2.8) | 0.17 | 14 | 0.5 (0.3, 0.9) |
Blood albumin decreased | 17 | 2.5 (1.6, 4.0) | 14 | 3.9 (2.3, 6.5) | 0.25 | 0 | (0, 0.1) |
Neutropenia | 15 | 2.2 (1.4, 3.7) | 11 | 3.1 (1.7, 5.4) | 0.41 | 0 | (0, 0.1) |
Abdominal pain | 15 | 2.2 (1.4, 3.7) | 7 | 2.0 (1.0, 4.0) | 0.83 | 12 | 0.5 (0.3, 0.8) |
ALT increased | 15 | 2.2 (1.4, 3.7) | 6 | 1.7 (0.8, 3.6) | 0.65 | 0 | (0, 0.1) |
Blood potassium increased | 15 | 2.2 (1.4, 3.7) | 4 | 1.1 (0.4, 2.8) | 0.23 | 0 | (0, 0.1) |
Haemoglobin decreased | 14 | 2.1 (1.3, 3.5) | 6 | 1.7 (0.8, 3.6) | 0.81 | 1 | 0.04 (0.002, 0.2) |
Nasopharyngitis | 14 | 2.1 (1.3, 3.5) | 3 | 0.8 (0.2, 2.4) | 0.20 | 7 | 0.3 (0.1, 0.6) |
Conjunctivitis | 13 | 1.9 (1.1, 3.3) | 5 | 1.4 (0.6, 3.2) | 0.62 | 0 | (0, 0.1) |
Haematocrit decreased | 13 | 1.9 (1.1, 3.3) | 4 | 1.1 (0.4, 2.8) | 0.44 | 0 | (0, 0.1) |
Headache | 11 | 1.6 (0.9, 2.9) | 2 | 0.6 (0.1, 2.0) | 0.24 | 15 | 0.6 (0.4, 1.0) |
Monocytosis | 10 | 1.5 (0.8, 2.7) | 10 | 2.8 (1.5, 5.1) | 0.16 | 0 | (0, 0.1) |
Helminthic infection | 9 | 1.3 (0.7, 2.5) | 2 | 0.6 (0.1, 2.0) | 0.35 | 0 | (0, 0.1) |
WBC count increased | 9 | 1.3 (0.7, 2.5) | 2 | 0.6 (0.1, 2.0) | 0.35 | 0 | (0, 0.1) |
Decreased appetite | 8 | 1.2 (0.6, 2.3) | 1 | 0.3 (0.14, 1.6) | 0.17 | 13 | 0.5 (0.3, 0.9) |
Infection parasitic | 7 | 1.0 (0.5, 2.2) | 1 | 0.3 (0.14, 1.6) | 0.27 | 0 | (0, 0.1) |
Splenomegaly | 6 | 0.9 (0.4, 1.9) | 4 | 1.1 (0.4, 2.8) | 0.75 | 2 | 0.1 (0.01, 0.3) |
Diarrhoea | 6 | 0.9 (0.4, 1.9) | 4 | 1.1 (0.4, 2.8) | 0.75 | 37 | 1.4 (1.0, 2.0) |
Blood creatinine decreased | 5 | 0.7 (0.3, 1.7) | 6 | 1.7 (0.8, 3.6) | 0.21 | 0 | (0, 0.1) |
Varicella | 4 | 0.6 (0.2, 1.5) | 4 | 1.1 (0.4, 2.8) | 0.46 | 1 | 0.04 (0.002, 0.1) |
Pneumonia | 3 | 0.4 (0.1, 1.3) | 5 | 1.4 (0.6, 3.2) | 0.14 | 2 | 0.1 (0.01, 0.3) |
Enterocolitis | 1 | 0.1 (0.008, 0.8) | 4 | 1.1 (0.4, 2.8) | 0.053 | 0 | (0, 0.1) |