Table 8.
Comparison of AE-incidences between specific mAbs and the whole patient population
| Incidence for specific mAb | Number of AEs | Incidence in whole population | Total number of AEs | X2 | P | |
|---|---|---|---|---|---|---|
| AEs with lower incidences in mAb groups | ||||||
| R1507 | ||||||
| Hyperglycaemia | 11.0 | 29 | 15.0 | 116 | 16.9961 | 0.0000 |
| Thrombocytopenia | 5.7 | 15 | 11.0 | 85 | 13.4768 | 0.0002 |
| Neutropenia | 2.7 | 7 | 5.2 | 40 | 4.4013 | 0.0359 |
| Hypertriglyceridaemia | 0.0 | 0 | 5.4 | 42 | 16.1373 | 0.0001 |
| Leukocytes | 0.0 | 0 | 3.4 | 26 | 9.1201 | 0.0025 |
| Hypercholesterolaemia | 0.0 | 0 | 3.8 | 29 | 10.7523 | 0.0010 |
| Neuropathy | 0.0 | 0 | 2.1 | 16 | 4.4628 | 0.0346 |
| Cixutumumab | ||||||
| Fatigue | 20.5 | 35 | 28.9 | 223 | 4.9917 | 0.0255 |
| Diarrhoea | 6.4 | 11 | 18.4 | 142 | 14.7348 | 0.0001 |
| Musculoskeletal pain | 0.6 | 1 | 7.5 | 58 | 11.4566 | 0.0007 |
| Pain | 0.6 | 1 | 8.8 | 68 | 13.9597 | 0.0002 |
| Constipation | 2.3 | 4 | 5.2 | 40 | 4.2062 | 0.0403 |
| Pyrexia | 1.2 | 2 | 4.0 | 31 | 4.3009 | 0.0381 |
| Cough | 0.0 | 0 | 4.3 | 33 | 8.5063 | 0.0035 |
| Figitumumab | ||||||
| Hyperglycaemia | 12.7 | 26 | 15.0 | 116 | 16.2414 | 0.0001 |
| Fatigue | 21.1 | 43 | 28.9 | 223 | 4.9612 | 0.0259 |
| Skin reaction | 8.3 | 17 | 19.7 | 152 | 14.5335 | 0.0001 |
| Pain | 1.0 | 2 | 8.8 | 68 | 14.8512 | 0.0001 |
| Muco/stomatitis | 10.3 | 21 | 12.0 | 93 | 10.2296 | 0.0014 |
| Constipation | 0.0 | 0 | 5.2 | 40 | 12.2793 | 0.0005 |
| Pyrexia | 0.0 | 0 | 4.0 | 31 | 9.2086 | 0.0024 |
| Cough | 0.0 | 0 | 4.3 | 33 | 9.8750 | 0.0017 |
| AEs with higher incidences in mAb groups | ||||||
| R1507 | ||||||
| Nausea and vomiting | 27.7 | 73 | 17.4 | 134 | 13.0384 | 0.0003 |
| Fatigue | 46.6 | 123 | 28.9 | 223 | 27.7232 | 0.0000 |
| Diarrhoea | 35.2 | 93 | 18.4 | 142 | 31.7855 | 0.0000 |
| Skin reaction | 35.2 | 93 | 19.7 | 152 | 26.3049 | 0.0000 |
| Pain | 24.2 | 64 | 8.8 | 68 | 42.1505 | 0.0000 |
| Muco/stomatitis | 15.2 | 40 | 12.0 | 93 | 10.7145 | 0.0011 |
| Headache | 10.2 | 27 | 4.9 | 38 | 10.5165 | 0.0012 |
| Constipation | 13.6 | 36 | 5.2 | 40 | 21.4960 | 0.0000 |
| Muscle spasm | 5.7 | 15 | 3.1 | 24 | 4.0809 | 0.0434 |
| Pyrexia | 8.0 | 21 | 4.0 | 31 | 7.1672 | 0.0074 |
| Dyspnoea | 10.2 | 27 | 3.5 | 27 | 18.0338 | 0.0000 |
| Cough | 12.5 | 33 | 4.3 | 33 | 22.6890 | 0.0000 |
| Dyspepsia | 4.5 | 12 | 0.6 | 5 | 16.1279 | 0.0001 |
| Elevated ALK phosphatase | 4.5 | 12 | 1.8 | 14 | 6.1119 | 0.0134 |
| Dehydration | 4.9 | 13 | 2.2 | 17 | 5.3829 | 0.0203 |
| Paronychia | 4.5 | 12 | 1.6 | 12 | 7.8280 | 0.0051 |
| Cixutumumab | ||||||
| Hyperglycaemia | 24.0 | 41 | 15.0 | 116 | 23.3586 | 0.0000 |
| Thrombocytopenia | 14.6 | 25 | 11.0 | 85 | 10.0313 | 0.0015 |
| Elevated AST/ALT | 8.8 | 15 | 7.6 | 59 | 4.1693 | 0.0412 |
| Muco/stomatitis | 16.4 | 28 | 12.0 | 93 | 12.2882 | 0.0005 |
| Hypertriglyceridaemia | 18.1 | 31 | 5.4 | 42 | 32.1086 | 0.0000 |
| Hypercholesterolaemia | 14.6 | 25 | 3.8 | 29 | 30.5818 | 0.0000 |
| Figitumumab | ||||||
| Anaemia | 16.2 | 33 | 9.8 | 76 | 6.5211 | 0.0107 |
| Thrombocytopenia | 15.7 | 32 | 11.0 | 85 | 11.1615 | 0.0008 |
| Elevated AST/ALT | 13.2 | 27 | 7.6 | 59 | 9.6979 | 0.0018 |
| Neutropenia | 11.8 | 24 | 5.2 | 40 | 12.6551 | 0.0004 |
| Leukocytes | 11.8 | 24 | 3.4 | 26 | 23.4071 | 0.0000 |
| Neuropathy | 7.8 | 16 | 2.1 | 16 | 16.9329 | 0.0000 |