Health outcome of interest | After advanced stage date (n=12,659) | After anti-cancer therapy date (n=7,723) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Events | Person-years | IRa | 95% CI | Events | Person-years | IR | 95% CI | |||
Serious infectionb | 6662 | 25868 | 25.78 | 25.17 | 26.41 | 5,862 | 15938 | 41.42 | 40.36 | 42.49 |
Rash | ||||||||||
Any rash | 686 | 22684 | 3.02 | 2.8 | 3.26 | 431 | 14095 | 3.06 | 2.78 | 3.36 |
Severe cutaneous rash safety events | 87 | 25534 | 0.34 | 0.27 | 0.42 | 62 | 15752 | 0.39 | 0.3 | 0.5 |
Colitis | 725 | 23251 | 3.12 | 2.9 | 3.35 | 464 | 14567 | 3.19 | 2.91 | 3.49 |
Pneumonitis | ||||||||||
Interstitial lung disease | 119 | 25622 | 0.46 | 0.39 | 0.55 | 62 | 15812 | 0.39 | 0.3 | 0.5 |
Hypersensitivity pneumonitis | ≤10 | n/a | 0.03 | 0.02 | 0.06 | ≤10 | n/a | 0.03 | 0.01 | 0.06 |
Pneumonitis or acute interstitial pneumonitis | 137 | 25653 | 0.53 | 0.45 | 0.63 | 83 | 15824 | 0.52 | 0.42 | 0.65 |
Hepatitis | ||||||||||
Hepatic failure | 764 | 23057 | 3.31 | 3.08 | 3.55 | 510 | 14112 | 3.61 | 3.31 | 3.94 |
Autoimmune hepatitis | ≤10 | n/a | 0.02 | 0.01 | 0.05 | ≤10 | n/a | 0.03 | 0.01 | 0.07 |
Hepatitis (not specified as viral) | 66 | 25559 | 0.26 | 0.2 | 0.33 | 23 | 15798 | 0.15 | 0.09 | 0.21 |
Liver disorder | 1439 | 21567 | 6.67 | 6.33 | 7.02 | 960 | 13128 | 7.31 | 6.86 | 7.79 |
Transaminases increased | 272 | 25086 | 1.08 | 0.96 | 1.22 | 169 | 15483 | 1.09 | 0.94 | 1.27 |
Nephritis | 1966 | 21201 | 9.27 | 8.87 | 9.69 | 1,309 | 13361 | 9.80 | 9.28 | 10.34 |
Renal failure | 2057 | 21425 | 9.60 | 9.19 | 10.02 | 1,379 | 13524 | 10.20 | 9.67 | 10.75 |
Endocrinopathies | ||||||||||
Adrenal insufficiency | 87 | 25608 | 0.34 | 0.27 | 0.42 | 44 | 15839 | 0.28 | 0.2 | 0.37 |
Acute and chronic thyroiditis | 88 | 25310 | 0.35 | 0.28 | 0.43 | 45 | 15665 | 0.29 | 0.21 | 0.38 |
Diabetes mellitus, type 1 | 124 | 24894 | 0.50 | 0.42 | 0.59 | 65 | 15482 | 0.42 | 0.33 | 0.53 |
Diabetic ketoacidosis | 40 | 25745 | 0.16 | 0.11 | 0.21 | 20 | 15891 | 0.13 | 0.08 | 0.19 |
Hypogonadism | ≤10 | n/a | 0.02 | 0.01 | 0.05 | ≤10 | n/a | 0.01 | 0 | 0.03 |
Hypophysitis or hypopituitarism | 90 | 25653 | 0.35 | 0.28 | 0.43 | 49 | 15826 | 0.31 | 0.23 | 0.41 |
Hypothyroidism | 636 | 18796 | 3.38 | 3.13 | 3.65 | 325 | 12002 | 2.71 | 2.43 | 3.01 |
Thyroid hyperfunction disorders | 121 | 25084 | 0.48 | 0.4 | 0.57 | 59 | 15554 | 0.38 | 0.29 | 0.49 |
Other safety events | ||||||||||
Abdominal pain | 1825 | 5206 | 35.06 | 33.48 | 36.69 | 859 | 3098 | 27.73 | 25.92 | 29.63 |
Anemia | 2925 | 11827 | 24.73 | 23.85 | 25.64 | 1,978 | 7576 | 26.11 | 24.98 | 27.28 |
Anorexia | 649 | 24889 | 2.61 | 2.41 | 2.81 | 469 | 15316 | 3.06 | 2.79 | 3.35 |
Autoimmune disorder | 182 | 25347 | 0.72 | 0.62 | 0.83 | 135 | 15657 | 0.86 | 0.73 | 1.02 |
Backache | 1632 | 20754 | 7.86 | 7.49 | 8.25 | 963 | 13124 | 7.34 | 6.89 | 7.81 |
Constipation | 2086 | 18379 | 11.35 | 10.87 | 11.85 | 1,404 | 11460 | 12.25 | 11.62 | 12.91 |
Cough | 1421 | 19219 | 7.39 | 7.02 | 7.79 | 848 | 12341 | 6.87 | 6.42 | 7.35 |
Diarrhea | 1502 | 20365 | 7.38 | 7.01 | 7.76 | 1,028 | 12630 | 8.14 | 7.65 | 8.65 |
Disorders of bilirubin excretion | 66 | 25798 | 0.26 | 0.2 | 0.32 | 52 | 15904 | 0.33 | 0.25 | 0.43 |
Disorders of phosphorus metabolism | 294 | 25265 | 1.16 | 1.04 | 1.3 | 177 | 15637 | 1.13 | 0.97 | 1.31 |
Dizziness and giddiness | 977 | 21121 | 4.63 | 4.34 | 4.92 | 604 | 13504 | 4.47 | 4.13 | 4.84 |
Edema | 1773 | 20466 | 8.66 | 8.27 | 9.07 | 1,107 | 12978 | 8.53 | 8.04 | 9.04 |
Encephalitis | 18 | 25811 | 0.07 | 0.04 | 0.11 | 13 | 15904 | 0.08 | 0.05 | 0.14 |
Fever | 1848 | 20676 | 8.94 | 8.54 | 9.35 | 1,313 | 12860 | 10.21 | 9.67 | 10.77 |
Guillain-Barre Syndrome | ≤10 | n/a | 0.02 | 0.01 | 0.05 | ≤10 | n/a | 0.03 | 0.01 | 0.06 |
Hypertension | 1243 | 10422 | 11.93 | 11.28 | 12.6 | 775 | 6820 | 11.36 | 10.58 | 12.18 |
Hypopotassemia | 1808 | 20815 | 8.69 | 8.29 | 9.09 | 1,211 | 12983 | 9.33 | 8.81 | 9.86 |
Hyposmolality and/or hyponatremia | 1475 | 23036 | 6.40 | 6.08 | 6.74 | 965 | 14302 | 6.75 | 6.33 | 7.18 |
Hypoxemia | 1034 | 23624 | 4.38 | 4.12 | 4.65 | 590 | 14805 | 3.99 | 3.67 | 4.32 |
Iritis | 36 | 25653 | 0.14 | 0.1 | 0.19 | 13 | 15839 | 0.08 | 0.05 | 0.14 |
Leukocytosis | 1280 | 23275 | 5.50 | 5.2 | 5.81 | 792 | 14379 | 5.51 | 5.13 | 5.9 |
Localized superficial swelling, mass, or lump | 385 | 25036 | 1.54 | 1.39 | 1.7 | 240 | 15436 | 1.55 | 1.37 | 1.76 |
Lymphocytopenia | 17 | 25841 | 0.07 | 0.04 | 0.1 | 12 | 15926 | 0.08 | 0.04 | 0.13 |
Malaise and fatigue | 2945 | 14296 | 20.60 | 19.87 | 21.35 | 2,089 | 9143 | 22.85 | 21.88 | 23.84 |
Myasthenia gravis | ≤10 | n/a | 0.03 | 0.01 | 0.05 | ≤10 | n/a | 0.02 | 0.01 | 0.05 |
Myocarditis | ≤10 | n/a | 0.01 | 0 | 0.02 | ≤10 | n/a | 0.01 | 0 | 0.04 |
Myositis | 352 | 22731 | 1.55 | 1.39 | 1.72 | 192 | 14275 | 1.34 | 1.16 | 1.55 |
Nausea and vomiting | 3436 | 13816 | 24.87 | 24.05 | 25.71 | 2,615 | 8033 | 32.55 | 31.32 | 33.82 |
Pain in joint | 1584 | 14017 | 11.30 | 10.75 | 11.87 | 930 | 9254 | 10.05 | 9.42 | 10.71 |
Pain in limb | 1741 | 16749 | 10.39 | 9.91 | 10.89 | 1,048 | 10874 | 9.64 | 9.07 | 10.24 |
Pancreatitis (acute or autoimmune) | 146 | 25386 | 0.58 | 0.49 | 0.67 | 82 | 15678 | 0.52 | 0.42 | 0.65 |
Psoriasis | 59 | 25370 | 0.23 | 0.18 | 0.3 | 30 | 15634 | 0.19 | 0.13 | 0.27 |
Respiratory abnormalities | ≤10 | n/a | 0.01 | 0 | 0.02 | ≤10 | n/a | 0.01 | 0 | 0.03 |
Rheumatoid Arthritis | 130 | 24912 | 0.52 | 0.44 | 0.62 | 70 | 15387 | 0.45 | 0.36 | 0.57 |
Sarcoidosis | 32 | 25689 | 0.12 | 0.09 | 0.17 | ≤10 | n/a | 0.06 | 0.03 | 0.1 |
Systemic inflammatory response syndrome | 116 | 25634 | 0.45 | 0.38 | 0.54 | 82 | 15789 | 0.52 | 0.42 | 0.64 |
Thrombocytopenia | 1389 | 23210 | 5.98 | 5.68 | 6.31 | 1,181 | 13985 | 8.44 | 7.97 | 8.94 |
Uveitis | ≤10 | n/a | 0.00 | 0 | 0.02 | 0 | 15938 | 0.00 | 0 | 0.02 |
Vitiligo | ≤10 | n/a | 0.03 | 0.01 | 0.05 | ≤10 | n/a | 0.04 | 0.02 | 0.08 |
Overall Mortality | 3051 | 18414 | 16.57 | 15.99 | 17.16 | 1903 | 8731 | 21.80 | 20.83 | 22.79 |