| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 4924 | 1374853-91-4 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation and plays a key role in in tumor evasion from host immunity.
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 28, 2016 | PMDA | MSD K.K. | |
| July 17, 2015 | EMA | Merck Sharp & Dohme Limited | |
| Sept. 4, 2014 | FDA | MERCK SHARP DOHME |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 2369.65 | 16.21 | 967 | 23054 | 67157 | 50513946 |
| Product use in unapproved indication | 636.42 | 16.21 | 488 | 23533 | 115331 | 50465772 |
| Immune-mediated adverse reaction | 496.64 | 16.21 | 89 | 23932 | 172 | 50580931 |
| Immune-mediated lung disease | 305.03 | 16.21 | 63 | 23958 | 324 | 50580779 |
| Pneumonitis | 273.89 | 16.21 | 172 | 23849 | 29338 | 50551765 |
| Tumour pseudoprogression | 256.50 | 16.21 | 50 | 23971 | 180 | 50580923 |
| Hypothyroidism | 246.34 | 16.21 | 170 | 23851 | 33955 | 50547148 |
| Colitis | 243.58 | 16.21 | 177 | 23844 | 38352 | 50542751 |
| Immune-mediated enterocolitis | 241.87 | 16.21 | 63 | 23958 | 997 | 50580106 |
| Immune-mediated hepatitis | 231.99 | 16.21 | 59 | 23962 | 845 | 50580258 |
| Death | 218.67 | 16.21 | 478 | 23543 | 324901 | 50256202 |
| Immune-mediated hypothyroidism | 194.79 | 16.21 | 33 | 23988 | 37 | 50581066 |
| Tubulointerstitial nephritis | 191.60 | 16.21 | 108 | 23913 | 15103 | 50566000 |
| Hepatitis | 190.86 | 16.21 | 141 | 23880 | 31312 | 50549791 |
| Myocarditis | 189.94 | 16.21 | 87 | 23934 | 7860 | 50573243 |
| Immune-mediated hepatic disorder | 163.13 | 16.21 | 32 | 23989 | 120 | 50580983 |
| Hypophysitis | 156.78 | 16.21 | 49 | 23972 | 1525 | 50579578 |
| Immune-mediated myocarditis | 147.18 | 16.21 | 27 | 23994 | 63 | 50581040 |
| Autoimmune colitis | 128.25 | 16.21 | 32 | 23989 | 422 | 50580681 |
| Vitiligo | 127.93 | 16.21 | 39 | 23982 | 1115 | 50579988 |
| Type 1 diabetes mellitus | 127.61 | 16.21 | 50 | 23971 | 3063 | 50578040 |
| Therapy partial responder | 126.37 | 16.21 | 62 | 23959 | 6529 | 50574574 |
| Thyroiditis | 125.88 | 16.21 | 43 | 23978 | 1779 | 50579324 |
| Immune-mediated dermatitis | 113.23 | 16.21 | 20 | 24001 | 34 | 50581069 |
| Autoimmune hypothyroidism | 108.04 | 16.21 | 22 | 23999 | 104 | 50580999 |
| Off label use | 105.27 | 16.21 | 474 | 23547 | 473952 | 50107151 |
| Lichenoid keratosis | 105.12 | 16.21 | 35 | 23986 | 1337 | 50579766 |
| Immune-mediated thyroiditis | 103.37 | 16.21 | 19 | 24002 | 45 | 50581058 |
| Adrenal insufficiency | 100.46 | 16.21 | 70 | 23951 | 14173 | 50566930 |
| Immune-mediated arthritis | 97.75 | 16.21 | 17 | 24004 | 25 | 50581078 |
| Hyperthyroidism | 95.75 | 16.21 | 64 | 23957 | 12111 | 50568992 |
| Nephritis | 94.78 | 16.21 | 36 | 23985 | 2026 | 50579077 |
| Myasthenia gravis | 94.76 | 16.21 | 42 | 23979 | 3510 | 50577593 |
| Adverse event | 92.62 | 16.21 | 109 | 23912 | 43654 | 50537449 |
| Fulminant type 1 diabetes mellitus | 91.71 | 16.21 | 23 | 23998 | 310 | 50580793 |
| Autoimmune hepatitis | 88.25 | 16.21 | 51 | 23970 | 7468 | 50573635 |
| Adrenocorticotropic hormone deficiency | 86.37 | 16.21 | 21 | 24000 | 247 | 50580856 |
| Immune-mediated pancreatitis | 85.07 | 16.21 | 16 | 24005 | 45 | 50581058 |
| Myositis | 83.19 | 16.21 | 50 | 23971 | 7870 | 50573233 |
| Product use issue | 76.49 | 16.21 | 198 | 23823 | 149277 | 50431826 |
| Inappropriate schedule of product administration | 75.60 | 16.21 | 128 | 23893 | 71703 | 50509400 |
| Autoimmune thyroiditis | 75.47 | 16.21 | 35 | 23986 | 3250 | 50577853 |
| Drug hypersensitivity | 75.40 | 16.21 | 14 | 24007 | 250996 | 50330107 |
| Drug ineffective | 66.59 | 16.21 | 186 | 23835 | 819147 | 49761956 |
| Hepatic function abnormal | 65.19 | 16.21 | 79 | 23942 | 32602 | 50548501 |
| Immune-mediated hyperthyroidism | 62.92 | 16.21 | 11 | 24010 | 17 | 50581086 |
| Joint swelling | 61.39 | 16.21 | 20 | 24001 | 245266 | 50335837 |
| Renal tubular necrosis | 60.32 | 16.21 | 45 | 23976 | 10123 | 50570980 |
| Immune-mediated gastritis | 59.88 | 16.21 | 9 | 24012 | 0 | 50581103 |
| Fall | 58.74 | 16.21 | 44 | 23977 | 334888 | 50246215 |
| Cholestasis | 58.32 | 16.21 | 66 | 23955 | 25335 | 50555768 |
| Nasopharyngitis | 57.40 | 16.21 | 11 | 24010 | 192916 | 50388187 |
| Autoimmune arthritis | 57.23 | 16.21 | 11 | 24010 | 36 | 50581067 |
| Hepatotoxicity | 56.24 | 16.21 | 67 | 23954 | 27159 | 50553944 |
| Neoplasm progression | 55.75 | 16.21 | 69 | 23952 | 29088 | 50552015 |
| Immune-mediated nephritis | 53.18 | 16.21 | 11 | 24010 | 57 | 50581046 |
| Abdominal discomfort | 52.72 | 16.21 | 22 | 23999 | 231619 | 50349484 |
| Interstitial lung disease | 51.03 | 16.21 | 91 | 23930 | 53085 | 50528018 |
| Diabetic ketoacidosis | 50.81 | 16.21 | 52 | 23969 | 17820 | 50563283 |
| Immune-mediated myositis | 50.77 | 16.21 | 19 | 24002 | 1026 | 50580077 |
| Systemic lupus erythematosus | 48.87 | 16.21 | 5 | 24016 | 140617 | 50440486 |
| Dizziness | 48.35 | 16.21 | 56 | 23965 | 346313 | 50234790 |
| Lichen planus | 48.33 | 16.21 | 22 | 23999 | 1957 | 50579146 |
| Cholangitis | 48.33 | 16.21 | 29 | 23992 | 4550 | 50576553 |
| Drug intolerance | 47.97 | 16.21 | 22 | 23999 | 219082 | 50362021 |
| Blood thyroid stimulating hormone increased | 47.83 | 16.21 | 32 | 23989 | 6060 | 50575043 |
| Immune-mediated endocrinopathy | 46.57 | 16.21 | 7 | 24014 | 0 | 50581103 |
| Pemphigoid | 46.31 | 16.21 | 31 | 23990 | 5876 | 50575227 |
| Sinusitis | 46.15 | 16.21 | 12 | 24009 | 170546 | 50410557 |
| Exposure during pregnancy | 45.65 | 16.21 | 3 | 24018 | 121012 | 50460091 |
| Secondary adrenocortical insufficiency | 45.58 | 16.21 | 18 | 24003 | 1125 | 50579978 |
| Polymyalgia rheumatica | 45.22 | 16.21 | 23 | 23998 | 2613 | 50578490 |
| Acute kidney injury | 44.53 | 16.21 | 220 | 23801 | 227838 | 50353265 |
| Swelling | 44.23 | 16.21 | 20 | 24001 | 200852 | 50380251 |
| Tumour hyperprogression | 43.96 | 16.21 | 10 | 24011 | 86 | 50581017 |
| Uveitis | 43.95 | 16.21 | 36 | 23985 | 9274 | 50571829 |
| Metastases to central nervous system | 43.81 | 16.21 | 39 | 23982 | 11243 | 50569860 |
| Hypersensitivity | 43.50 | 16.21 | 24 | 23997 | 215137 | 50365966 |
| Condition aggravated | 42.55 | 16.21 | 47 | 23974 | 297011 | 50284092 |
| Hypopituitarism | 42.45 | 16.21 | 16 | 24005 | 881 | 50580222 |
| Drug effective for unapproved indication | 41.83 | 16.21 | 20 | 24001 | 1989 | 50579114 |
| Pyrexia | 40.75 | 16.21 | 314 | 23707 | 379889 | 50201214 |
| Lymphocytic hypophysitis | 40.64 | 16.21 | 11 | 24010 | 203 | 50580900 |
| Glossodynia | 40.44 | 16.21 | 4 | 24017 | 115565 | 50465538 |
| Subacute cutaneous lupus erythematosus | 39.97 | 16.21 | 20 | 24001 | 2195 | 50578908 |
| Therapeutic product effect decreased | 39.94 | 16.21 | 8 | 24013 | 136042 | 50445061 |
| Arthropathy | 39.26 | 16.21 | 13 | 24008 | 157893 | 50423210 |
| Autoimmune pancreatitis | 39.25 | 16.21 | 11 | 24010 | 232 | 50580871 |
| Autoimmune myocarditis | 38.91 | 16.21 | 8 | 24013 | 40 | 50581063 |
| Headache | 38.76 | 16.21 | 118 | 23903 | 506417 | 50074686 |
| Maternal exposure during pregnancy | 38.27 | 16.21 | 14 | 24007 | 159764 | 50421339 |
| Alopecia | 38.23 | 16.21 | 36 | 23985 | 245011 | 50336092 |
| Hepatocellular injury | 38.17 | 16.21 | 54 | 23967 | 25893 | 50555210 |
| Tumour associated fever | 37.99 | 16.21 | 10 | 24011 | 165 | 50580938 |
| Skin toxicity | 36.74 | 16.21 | 23 | 23998 | 3890 | 50577213 |
| Myasthenic syndrome | 36.57 | 16.21 | 10 | 24011 | 192 | 50580911 |
| Eastern Cooperative Oncology Group performance status worsened | 36.18 | 16.21 | 13 | 24008 | 625 | 50580478 |
| Autoimmune nephritis | 35.99 | 16.21 | 11 | 24010 | 317 | 50580786 |
| Pain | 34.93 | 16.21 | 149 | 23872 | 578754 | 50002349 |
| Synovitis | 34.89 | 16.21 | 8 | 24013 | 123857 | 50457246 |
| Glucocorticoid deficiency | 34.62 | 16.21 | 10 | 24011 | 236 | 50580867 |
| Drug interaction | 33.95 | 16.21 | 27 | 23994 | 199594 | 50381509 |
| Transaminases increased | 33.89 | 16.21 | 53 | 23968 | 27771 | 50553332 |
| Wound | 33.73 | 16.21 | 5 | 24016 | 105789 | 50475314 |
| Eosinophilic fasciitis | 32.83 | 16.21 | 8 | 24013 | 95 | 50581008 |
| Hepatitis toxic | 32.77 | 16.21 | 19 | 24002 | 2797 | 50578306 |
| Neutropenia | 32.68 | 16.21 | 148 | 23873 | 147817 | 50433286 |
| Overdose | 31.14 | 16.21 | 5 | 24016 | 99722 | 50481381 |
| Immune-mediated neuropathy | 30.92 | 16.21 | 5 | 24016 | 3 | 50581100 |
| Myelosuppression | 30.81 | 16.21 | 35 | 23986 | 13482 | 50567621 |
| Blood pressure abnormal | 30.76 | 16.21 | 34 | 23987 | 12713 | 50568390 |
| Thrombocytopenia | 30.69 | 16.21 | 131 | 23890 | 127542 | 50453561 |
| Discomfort | 30.52 | 16.21 | 7 | 24014 | 108373 | 50472730 |
| Rash maculo-papular | 30.04 | 16.21 | 49 | 23972 | 26592 | 50554511 |
| EGFR gene mutation | 29.90 | 16.21 | 9 | 24012 | 246 | 50580857 |
| Toxic epidermal necrolysis | 29.86 | 16.21 | 43 | 23978 | 20949 | 50560154 |
| Neurofibrosarcoma | 29.54 | 16.21 | 8 | 24013 | 148 | 50580955 |
| Hypertension | 29.36 | 16.21 | 186 | 23835 | 211017 | 50370086 |
| Amputation stump pain | 29.02 | 16.21 | 6 | 24015 | 31 | 50581072 |
| Pulmonary embolism | 28.95 | 16.21 | 110 | 23911 | 101594 | 50479509 |
| Bronchitis | 28.80 | 16.21 | 7 | 24014 | 104152 | 50476951 |
| Decreased appetite | 28.59 | 16.21 | 178 | 23843 | 200745 | 50380358 |
| Autoimmune dermatitis | 28.41 | 16.21 | 6 | 24015 | 35 | 50581068 |
| Cholangitis sclerosing | 27.94 | 16.21 | 13 | 24008 | 1216 | 50579887 |
| Thyroid disorder | 27.51 | 16.21 | 32 | 23989 | 12645 | 50568458 |
| Polyglandular autoimmune syndrome type II | 27.22 | 16.21 | 6 | 24015 | 44 | 50581059 |
| Rheumatoid arthritis | 26.88 | 16.21 | 34 | 23987 | 202516 | 50378587 |
| Immune-mediated hypophysitis | 26.87 | 16.21 | 5 | 24016 | 13 | 50581090 |
| Autoimmune endocrine disorder | 26.61 | 16.21 | 4 | 24017 | 0 | 50581103 |
| Toxicity to various agents | 25.85 | 16.21 | 38 | 23983 | 212461 | 50368642 |
| Immune-mediated cholangitis | 25.65 | 16.21 | 5 | 24016 | 18 | 50581085 |
| Diarrhoea | 25.49 | 16.21 | 406 | 23615 | 588070 | 49993033 |
| Palmar-plantar erythrodysaesthesia syndrome | 25.47 | 16.21 | 39 | 23982 | 20059 | 50561044 |
| Neonatal respiratory depression | 25.47 | 16.21 | 6 | 24015 | 61 | 50581042 |
| Aspartate aminotransferase increased | 25.27 | 16.21 | 88 | 23933 | 77910 | 50503193 |
| Contusion | 24.94 | 16.21 | 11 | 24010 | 112172 | 50468931 |
| Pericardial effusion | 24.80 | 16.21 | 44 | 23977 | 25545 | 50555558 |
| Pleural effusion | 24.76 | 16.21 | 90 | 23931 | 81364 | 50499739 |
| Weight increased | 24.66 | 16.21 | 36 | 23985 | 201855 | 50379248 |
| Metastases to adrenals | 24.46 | 16.21 | 10 | 24011 | 684 | 50580419 |
| Infusion related reaction | 24.05 | 16.21 | 27 | 23994 | 169530 | 50411573 |
| Thyroid hormones increased | 24.04 | 16.21 | 8 | 24013 | 305 | 50580798 |
| Rash pruritic | 24.02 | 16.21 | 63 | 23958 | 47783 | 50533320 |
| Oligodipsia | 24.00 | 16.21 | 5 | 24016 | 27 | 50581076 |
| Cutaneous sarcoidosis | 23.79 | 16.21 | 8 | 24013 | 315 | 50580788 |
| Meningitis aseptic | 23.79 | 16.21 | 18 | 24003 | 4134 | 50576969 |
| BRAF V600E mutation positive | 23.41 | 16.21 | 5 | 24016 | 31 | 50581072 |
| Immune thrombocytopenia | 23.41 | 16.21 | 25 | 23996 | 8992 | 50572111 |
| Immune-mediated encephalitis | 23.27 | 16.21 | 6 | 24015 | 91 | 50581012 |
| Neuropathy peripheral | 23.02 | 16.21 | 99 | 23922 | 96658 | 50484445 |
| Peripheral swelling | 22.99 | 16.21 | 39 | 23982 | 205897 | 50375206 |
| Liver disorder | 22.92 | 16.21 | 53 | 23968 | 37169 | 50543934 |
| Duodenitis | 22.89 | 16.21 | 16 | 24005 | 3252 | 50577851 |
| Febrile neutropenia | 22.53 | 16.21 | 99 | 23922 | 97568 | 50483535 |
| Rash morbilliform | 22.46 | 16.21 | 15 | 24006 | 2831 | 50578272 |
| Metastatic malignant melanoma | 22.37 | 16.21 | 11 | 24010 | 1163 | 50579940 |
| Serous retinal detachment | 22.03 | 16.21 | 7 | 24014 | 230 | 50580873 |
| No adverse event | 21.99 | 16.21 | 49 | 23972 | 33529 | 50547574 |
| Encephalitis | 21.93 | 16.21 | 22 | 23999 | 7358 | 50573745 |
| Tumour pain | 21.88 | 16.21 | 11 | 24010 | 1219 | 50579884 |
| Blood corticotrophin decreased | 21.69 | 16.21 | 7 | 24014 | 242 | 50580861 |
| Insomnia | 21.53 | 16.21 | 31 | 23990 | 174834 | 50406269 |
| Female genital tract fistula | 21.24 | 16.21 | 16 | 24005 | 3650 | 50577453 |
| Diabetes mellitus | 21.08 | 16.21 | 61 | 23960 | 48972 | 50532131 |
| Musculoskeletal stiffness | 21.06 | 16.21 | 18 | 24003 | 128463 | 50452640 |
| Radiation pneumonitis | 21.03 | 16.21 | 11 | 24010 | 1324 | 50579779 |
| Circumstance or information capable of leading to medication error | 20.92 | 16.21 | 15 | 24006 | 3173 | 50577930 |
| Migraine | 20.92 | 16.21 | 5 | 24016 | 75275 | 50505828 |
| Mobility decreased | 20.90 | 16.21 | 6 | 24015 | 79942 | 50501161 |
| Autoimmune uveitis | 20.83 | 16.21 | 4 | 24017 | 13 | 50581090 |
| Loss of personal independence in daily activities | 20.80 | 16.21 | 4 | 24017 | 70046 | 50511057 |
| Pancytopenia | 20.78 | 16.21 | 87 | 23934 | 83943 | 50497160 |
| Cytokine release syndrome | 20.78 | 16.21 | 23 | 23998 | 8611 | 50572492 |
| Radiation associated pain | 20.63 | 16.21 | 5 | 24016 | 58 | 50581045 |
| Dermatitis bullous | 20.62 | 16.21 | 21 | 24000 | 7152 | 50573951 |
| Stevens-Johnson syndrome | 20.56 | 16.21 | 37 | 23984 | 21715 | 50559388 |
| Enterocolitis | 20.30 | 16.21 | 20 | 24001 | 6547 | 50574556 |
| Antinuclear antibody | 20.29 | 16.21 | 8 | 24013 | 498 | 50580605 |
| Vesical fistula | 20.25 | 16.21 | 5 | 24016 | 63 | 50581040 |
| Immune-mediated adrenal insuficiency | 19.96 | 16.21 | 3 | 24018 | 0 | 50581103 |
| Respiratory failure | 19.95 | 16.21 | 91 | 23930 | 91090 | 50490013 |
| Alanine aminotransferase increased | 19.95 | 16.21 | 89 | 23932 | 88270 | 50492833 |
| Silent thyroiditis | 19.57 | 16.21 | 5 | 24016 | 73 | 50581030 |
| Influenza | 19.55 | 16.21 | 9 | 24012 | 89529 | 50491574 |
| Acquired gene mutation | 19.54 | 16.21 | 9 | 24012 | 822 | 50580281 |
| Asthma | 19.48 | 16.21 | 9 | 24012 | 89328 | 50491775 |
| Parathyroid tumour malignant | 19.46 | 16.21 | 4 | 24017 | 20 | 50581083 |
| Cardiomyopathy | 19.41 | 16.21 | 30 | 23991 | 15556 | 50565547 |
| Adenocarcinoma | 19.40 | 16.21 | 13 | 24008 | 2468 | 50578635 |
| Cholecystitis | 19.13 | 16.21 | 28 | 23993 | 13843 | 50567260 |
| Pulmonary sarcoidosis | 19.12 | 16.21 | 9 | 24012 | 864 | 50580239 |
| Posterior reversible encephalopathy syndrome | 18.96 | 16.21 | 29 | 23992 | 14899 | 50566204 |
| Depression | 18.76 | 16.21 | 31 | 23990 | 165392 | 50415711 |
| Pulmonary granuloma | 18.56 | 16.21 | 10 | 24011 | 1278 | 50579825 |
| Metastases to abdominal wall | 18.54 | 16.21 | 5 | 24016 | 91 | 50581012 |
| Melanoma recurrent | 18.43 | 16.21 | 5 | 24016 | 93 | 50581010 |
| Ophthalmoplegia | 18.19 | 16.21 | 10 | 24011 | 1330 | 50579773 |
| Large intestine perforation | 18.10 | 16.21 | 20 | 24001 | 7474 | 50573629 |
| Tumour haemorrhage | 18.08 | 16.21 | 10 | 24011 | 1345 | 50579758 |
| Vital functions abnormal | 18.03 | 16.21 | 7 | 24014 | 418 | 50580685 |
| Giant cell arteritis | 17.85 | 16.21 | 11 | 24010 | 1809 | 50579294 |
| Muscle spasms | 17.79 | 16.21 | 20 | 24001 | 125533 | 50455570 |
| Malignant pleural effusion | 17.72 | 16.21 | 12 | 24009 | 2318 | 50578785 |
| Optic neuritis | 17.71 | 16.21 | 19 | 24002 | 6871 | 50574232 |
| Guillain-Barre syndrome | 17.59 | 16.21 | 14 | 24007 | 3463 | 50577640 |
| Exposure via body fluid | 17.51 | 16.21 | 7 | 24014 | 452 | 50580651 |
| Infection | 17.30 | 16.21 | 35 | 23986 | 172919 | 50408184 |
| Polyarthritis | 17.18 | 16.21 | 20 | 24001 | 7907 | 50573196 |
| Immune-mediated encephalopathy | 17.02 | 16.21 | 3 | 24018 | 5 | 50581098 |
| Ototoxicity | 16.94 | 16.21 | 9 | 24012 | 1118 | 50579985 |
| Sarcoidosis | 16.86 | 16.21 | 16 | 24005 | 5001 | 50576102 |
| Urogenital fistula | 16.78 | 16.21 | 5 | 24016 | 132 | 50580971 |
| Achromotrichia acquired | 16.67 | 16.21 | 3 | 24018 | 6 | 50581097 |
| B-cell aplasia | 16.45 | 16.21 | 4 | 24017 | 47 | 50581056 |
| Autoimmune disorder | 16.32 | 16.21 | 17 | 24004 | 5943 | 50575160 |
| Pneumonia moraxella | 16.30 | 16.21 | 4 | 24017 | 49 | 50581054 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 2646.45 | 14.80 | 1389 | 31527 | 72470 | 29469141 |
| Immune-mediated adverse reaction | 869.61 | 14.80 | 178 | 32738 | 269 | 29541342 |
| Pneumonitis | 464.31 | 14.80 | 323 | 32593 | 27721 | 29513890 |
| Product use in unapproved indication | 455.93 | 14.80 | 521 | 32395 | 86354 | 29455257 |
| Immune-mediated hepatic disorder | 378.41 | 14.80 | 86 | 32830 | 265 | 29541346 |
| Immune-mediated lung disease | 353.52 | 14.80 | 95 | 32821 | 673 | 29540938 |
| Interstitial lung disease | 350.56 | 14.80 | 374 | 32542 | 57344 | 29484267 |
| Immune-mediated enterocolitis | 346.11 | 14.80 | 111 | 32805 | 1542 | 29540069 |
| Immune-mediated myocarditis | 328.80 | 14.80 | 76 | 32840 | 258 | 29541353 |
| Immune-mediated hepatitis | 309.33 | 14.80 | 100 | 32816 | 1427 | 29540184 |
| Myasthenia gravis | 279.62 | 14.80 | 112 | 32804 | 3039 | 29538572 |
| Tumour pseudoprogression | 253.38 | 14.80 | 63 | 32853 | 313 | 29541298 |
| Adrenal insufficiency | 239.47 | 14.80 | 151 | 32765 | 10963 | 29530648 |
| Adverse event | 220.37 | 14.80 | 162 | 32754 | 15129 | 29526482 |
| Hypothyroidism | 214.66 | 14.80 | 162 | 32754 | 15744 | 29525867 |
| Colitis | 210.10 | 14.80 | 214 | 32702 | 31034 | 29510577 |
| Immune-mediated hypothyroidism | 194.61 | 14.80 | 39 | 32877 | 49 | 29541562 |
| Type 1 diabetes mellitus | 190.04 | 14.80 | 89 | 32827 | 3555 | 29538056 |
| Myocarditis | 178.31 | 14.80 | 125 | 32791 | 10831 | 29530780 |
| Therapy partial responder | 171.17 | 14.80 | 93 | 32823 | 5106 | 29536505 |
| Adrenocorticotropic hormone deficiency | 166.33 | 14.80 | 50 | 32866 | 552 | 29541059 |
| Hypophysitis | 164.37 | 14.80 | 67 | 32849 | 1903 | 29539708 |
| Off label use | 160.71 | 14.80 | 710 | 32206 | 300090 | 29241521 |
| Autoimmune hepatitis | 160.59 | 14.80 | 79 | 32837 | 3523 | 29538088 |
| Product use issue | 158.84 | 14.80 | 238 | 32678 | 51206 | 29490405 |
| Immune-mediated arthritis | 148.20 | 14.80 | 29 | 32887 | 29 | 29541582 |
| Tubulointerstitial nephritis | 145.10 | 14.80 | 135 | 32781 | 17508 | 29524103 |
| Myositis | 139.30 | 14.80 | 105 | 32811 | 10178 | 29531433 |
| Immune-mediated myositis | 138.83 | 14.80 | 56 | 32860 | 1547 | 29540064 |
| Vitiligo | 129.85 | 14.80 | 44 | 32872 | 732 | 29540879 |
| Death | 121.26 | 14.80 | 720 | 32196 | 341364 | 29200247 |
| Autoimmune colitis | 116.26 | 14.80 | 42 | 32874 | 851 | 29540760 |
| Hyperthyroidism | 114.61 | 14.80 | 87 | 32829 | 8521 | 29533090 |
| Immune-mediated dermatitis | 112.98 | 14.80 | 26 | 32890 | 86 | 29541525 |
| Pemphigoid | 110.72 | 14.80 | 81 | 32835 | 7500 | 29534111 |
| Immune-mediated renal disorder | 98.56 | 14.80 | 20 | 32896 | 28 | 29541583 |
| Inappropriate schedule of product administration | 98.29 | 14.80 | 177 | 32739 | 44295 | 29497316 |
| Drug interaction | 97.61 | 14.80 | 49 | 32867 | 197336 | 29344275 |
| Hepatitis | 91.09 | 14.80 | 114 | 32802 | 20669 | 29520942 |
| Nephritis | 89.74 | 14.80 | 45 | 32871 | 2091 | 29539520 |
| Completed suicide | 87.05 | 14.80 | 3 | 32913 | 90243 | 29451368 |
| Immune-mediated pancreatitis | 85.73 | 14.80 | 18 | 32898 | 33 | 29541578 |
| Tumour hyperprogression | 83.29 | 14.80 | 17 | 32899 | 25 | 29541586 |
| Secondary adrenocortical insufficiency | 76.63 | 14.80 | 33 | 32883 | 1078 | 29540533 |
| Thyroiditis | 76.27 | 14.80 | 39 | 32877 | 1889 | 29539722 |
| Overdose | 69.56 | 14.80 | 5 | 32911 | 79814 | 29461797 |
| Neoplasm progression | 68.97 | 14.80 | 94 | 32822 | 18518 | 29523093 |
| Fall | 68.51 | 14.80 | 58 | 32858 | 177120 | 29364491 |
| Immune thrombocytopenia | 68.09 | 14.80 | 62 | 32854 | 7815 | 29533796 |
| Immune-mediated thyroiditis | 67.59 | 14.80 | 15 | 32901 | 40 | 29541571 |
| Polymyalgia rheumatica | 67.56 | 14.80 | 31 | 32885 | 1180 | 29540431 |
| Diabetic ketoacidosis | 62.33 | 14.80 | 83 | 32833 | 15990 | 29525621 |
| Eyelid ptosis | 59.47 | 14.80 | 48 | 32868 | 5138 | 29536473 |
| Immune-mediated nephritis | 58.80 | 14.80 | 17 | 32899 | 162 | 29541449 |
| Cholangitis sclerosing | 58.54 | 14.80 | 27 | 32889 | 1040 | 29540571 |
| Hepatic function abnormal | 57.75 | 14.80 | 132 | 32784 | 39127 | 29502484 |
| Fulminant type 1 diabetes mellitus | 57.60 | 14.80 | 23 | 32893 | 618 | 29540993 |
| Hypopituitarism | 57.08 | 14.80 | 31 | 32885 | 1699 | 29539912 |
| Organising pneumonia | 56.36 | 14.80 | 46 | 32870 | 5002 | 29536609 |
| Skin toxicity | 54.40 | 14.80 | 40 | 32876 | 3731 | 29537880 |
| Immune-mediated encephalitis | 53.80 | 14.80 | 14 | 32902 | 86 | 29541525 |
| Immune-mediated gastritis | 52.72 | 14.80 | 10 | 32906 | 7 | 29541604 |
| Haemophagocytic lymphohistiocytosis | 51.50 | 14.80 | 61 | 32855 | 10443 | 29531168 |
| Immune-mediated hypophysitis | 51.12 | 14.80 | 11 | 32905 | 24 | 29541587 |
| Subacute cutaneous lupus erythematosus | 51.11 | 14.80 | 23 | 32893 | 836 | 29540775 |
| Autoimmune hypothyroidism | 48.61 | 14.80 | 11 | 32905 | 33 | 29541578 |
| Eastern Cooperative Oncology Group performance status worsened | 48.12 | 14.80 | 21 | 32895 | 709 | 29540902 |
| Encephalitis autoimmune | 47.78 | 14.80 | 19 | 32897 | 505 | 29541106 |
| Pneumonia bacterial | 47.04 | 14.80 | 55 | 32861 | 9288 | 29532323 |
| Autoimmune thyroiditis | 47.00 | 14.80 | 23 | 32893 | 1013 | 29540598 |
| Eosinophilic fasciitis | 46.79 | 14.80 | 12 | 32904 | 69 | 29541542 |
| Autoimmune arthritis | 45.97 | 14.80 | 11 | 32905 | 45 | 29541566 |
| Immune-mediated cholangitis | 45.40 | 14.80 | 11 | 32905 | 48 | 29541563 |
| Immune-mediated uveitis | 43.79 | 14.80 | 9 | 32907 | 14 | 29541597 |
| Dizziness | 42.92 | 14.80 | 92 | 32824 | 189592 | 29352019 |
| Autoimmune pancreatitis | 42.56 | 14.80 | 15 | 32901 | 282 | 29541329 |
| Pericarditis malignant | 42.35 | 14.80 | 9 | 32907 | 18 | 29541593 |
| Myasthenic syndrome | 41.49 | 14.80 | 16 | 32900 | 391 | 29541220 |
| Toxicity to various agents | 41.16 | 14.80 | 82 | 32834 | 173579 | 29368032 |
| Autoimmune myocarditis | 41.10 | 14.80 | 13 | 32903 | 172 | 29541439 |
| Lymphocytic hypophysitis | 40.62 | 14.80 | 13 | 32903 | 179 | 29541432 |
| Lichenoid keratosis | 40.60 | 14.80 | 27 | 32889 | 2143 | 29539468 |
| Headache | 40.53 | 14.80 | 83 | 32833 | 173924 | 29367687 |
| Diarrhoea | 40.01 | 14.80 | 554 | 32362 | 332144 | 29209467 |
| Immune-mediated cytopenia | 39.51 | 14.80 | 8 | 32908 | 11 | 29541600 |
| Toxic epidermal necrolysis | 38.48 | 14.80 | 71 | 32845 | 18082 | 29523529 |
| Myelosuppression | 38.28 | 14.80 | 57 | 32859 | 12170 | 29529441 |
| Pleural effusion | 38.23 | 14.80 | 170 | 32746 | 71738 | 29469873 |
| Lung disorder | 38.09 | 14.80 | 96 | 32820 | 30266 | 29511345 |
| Hepatotoxicity | 38.02 | 14.80 | 70 | 32846 | 17797 | 29523814 |
| Pulmonary toxicity | 37.47 | 14.80 | 36 | 32880 | 4854 | 29536757 |
| Rash | 37.23 | 14.80 | 348 | 32568 | 189471 | 29352140 |
| Drug hypersensitivity | 36.83 | 14.80 | 15 | 32901 | 68391 | 29473220 |
| Decreased appetite | 36.15 | 14.80 | 281 | 32635 | 145061 | 29396550 |
| Colitis microscopic | 35.58 | 14.80 | 23 | 32893 | 1740 | 29539871 |
| Hepatocellular injury | 35.26 | 14.80 | 75 | 32841 | 21168 | 29520443 |
| Adrenal disorder | 34.11 | 14.80 | 17 | 32899 | 779 | 29540832 |
| Immune-mediated endocrinopathy | 32.94 | 14.80 | 7 | 32909 | 14 | 29541597 |
| Autoimmune nephritis | 32.91 | 14.80 | 11 | 32905 | 175 | 29541436 |
| Blood thyroid stimulating hormone abnormal | 32.72 | 14.80 | 12 | 32904 | 254 | 29541357 |
| Encephalitis | 32.61 | 14.80 | 38 | 32878 | 6392 | 29535219 |
| Hospitalisation | 32.35 | 14.80 | 6 | 32910 | 45982 | 29495629 |
| Primary biliary cholangitis | 31.77 | 14.80 | 10 | 32906 | 130 | 29541481 |
| Agitation | 31.51 | 14.80 | 9 | 32907 | 51295 | 29490316 |
| Drug-induced liver injury | 30.93 | 14.80 | 72 | 32844 | 21583 | 29520028 |
| Cholangitis | 30.88 | 14.80 | 40 | 32876 | 7497 | 29534114 |
| Bradycardia | 29.88 | 14.80 | 18 | 32898 | 65611 | 29476000 |
| Metastases to central nervous system | 29.46 | 14.80 | 38 | 32878 | 7093 | 29534518 |
| Electrocardiogram QT prolonged | 29.45 | 14.80 | 3 | 32913 | 36134 | 29505477 |
| Drug effective for unapproved indication | 29.41 | 14.80 | 19 | 32897 | 1436 | 29540175 |
| Depression | 29.19 | 14.80 | 31 | 32885 | 85116 | 29456495 |
| Hypothalamo-pituitary disorder | 29.19 | 14.80 | 15 | 32901 | 734 | 29540877 |
| Drug ineffective | 28.92 | 14.80 | 262 | 32654 | 362908 | 29178703 |
| Mucosal inflammation | 28.85 | 14.80 | 89 | 32827 | 31506 | 29510105 |
| Aggression | 28.84 | 14.80 | 3 | 32913 | 35538 | 29506073 |
| Hypotension | 28.81 | 14.80 | 115 | 32801 | 194239 | 29347372 |
| International normalised ratio increased | 28.74 | 14.80 | 7 | 32909 | 44365 | 29497246 |
| Thyroid disorder | 28.71 | 14.80 | 24 | 32892 | 2698 | 29538913 |
| Paraneoplastic neurological syndrome | 28.63 | 14.80 | 7 | 32909 | 32 | 29541579 |
| Haemoglobin decreased | 28.47 | 14.80 | 48 | 32868 | 108327 | 29433284 |
| Primary hypothyroidism | 28.45 | 14.80 | 7 | 32909 | 33 | 29541578 |
| Cardiac failure congestive | 28.42 | 14.80 | 26 | 32890 | 76555 | 29465056 |
| Melanoma recurrent | 28.32 | 14.80 | 9 | 32907 | 121 | 29541490 |
| Stevens-Johnson syndrome | 28.26 | 14.80 | 59 | 32857 | 16438 | 29525173 |
| Enteritis | 27.76 | 14.80 | 36 | 32880 | 6755 | 29534856 |
| Latent autoimmune diabetes in adults | 26.76 | 14.80 | 7 | 32909 | 44 | 29541567 |
| Autoimmune uveitis | 26.66 | 14.80 | 5 | 32911 | 3 | 29541608 |
| Hypertransaminasaemia | 26.60 | 14.80 | 26 | 32890 | 3580 | 29538031 |
| Silent thyroiditis | 26.49 | 14.80 | 7 | 32909 | 46 | 29541565 |
| Radiation pneumonitis | 26.34 | 14.80 | 21 | 32895 | 2208 | 29539403 |
| Radiation necrosis | 25.78 | 14.80 | 8 | 32908 | 99 | 29541512 |
| Mixed liver injury | 25.70 | 14.80 | 20 | 32896 | 2031 | 29539580 |
| Transaminases increased | 25.69 | 14.80 | 69 | 32847 | 22593 | 29519018 |
| Injection site pain | 25.67 | 14.80 | 3 | 32913 | 32443 | 29509168 |
| Intentional product misuse | 25.53 | 14.80 | 4 | 32912 | 34657 | 29506954 |
| Insomnia | 25.51 | 14.80 | 37 | 32879 | 88724 | 29452887 |
| Hypersensitivity | 24.80 | 14.80 | 14 | 32902 | 52889 | 29488722 |
| Optic neuritis | 24.03 | 14.80 | 23 | 32893 | 3086 | 29538525 |
| Pain in extremity | 23.75 | 14.80 | 55 | 32861 | 110378 | 29431233 |
| Condition aggravated | 23.32 | 14.80 | 84 | 32832 | 146211 | 29395400 |
| Anxiety | 23.17 | 14.80 | 37 | 32879 | 85328 | 29456283 |
| Unevaluable event | 23.02 | 14.80 | 3 | 32913 | 29848 | 29511763 |
| Lymphangiosis carcinomatosa | 22.57 | 14.80 | 13 | 32903 | 799 | 29540812 |
| Dermatitis | 22.50 | 14.80 | 35 | 32881 | 7763 | 29533848 |
| Syncope | 22.34 | 14.80 | 35 | 32881 | 81336 | 29460275 |
| Hallucination | 22.18 | 14.80 | 11 | 32905 | 44701 | 29496910 |
| Lichen planus | 22.17 | 14.80 | 13 | 32903 | 826 | 29540785 |
| Loss of consciousness | 22.15 | 14.80 | 30 | 32886 | 74026 | 29467585 |
| Chest discomfort | 21.80 | 14.80 | 12 | 32904 | 45971 | 29495640 |
| Bacterial diarrhoea | 21.79 | 14.80 | 6 | 32910 | 47 | 29541564 |
| Autoimmune disorder | 21.62 | 14.80 | 16 | 32900 | 1507 | 29540104 |
| Autoimmune neuropathy | 21.57 | 14.80 | 6 | 32910 | 49 | 29541562 |
| Respiratory failure | 21.52 | 14.80 | 183 | 32733 | 96948 | 29444663 |
| Pericardial effusion | 21.50 | 14.80 | 62 | 32854 | 21146 | 29520465 |
| Cancer pain | 21.32 | 14.80 | 19 | 32897 | 2328 | 29539283 |
| Metastatic malignant melanoma | 21.24 | 14.80 | 17 | 32899 | 1798 | 29539813 |
| Keratoacanthoma | 21.07 | 14.80 | 11 | 32905 | 556 | 29541055 |
| Muscle spasms | 20.87 | 14.80 | 25 | 32891 | 65057 | 29476554 |
| Joint swelling | 20.71 | 14.80 | 15 | 32901 | 49615 | 29491996 |
| Cardiac arrest | 20.60 | 14.80 | 40 | 32876 | 85551 | 29456060 |
| Blood thyroid stimulating hormone increased | 20.35 | 14.80 | 21 | 32895 | 3084 | 29538527 |
| Blood pressure increased | 20.01 | 14.80 | 32 | 32884 | 73771 | 29467840 |
| Tremor | 19.83 | 14.80 | 32 | 32884 | 73506 | 29468105 |
| Seizure | 19.53 | 14.80 | 47 | 32869 | 93076 | 29448535 |
| Dermatomyositis | 19.51 | 14.80 | 13 | 32903 | 1035 | 29540576 |
| Guillain-Barre syndrome | 19.42 | 14.80 | 26 | 32890 | 5032 | 29536579 |
| Paraneoplastic syndrome | 19.30 | 14.80 | 10 | 32906 | 498 | 29541113 |
| Cutaneous sarcoidosis | 19.18 | 14.80 | 7 | 32909 | 146 | 29541465 |
| Coma | 19.13 | 14.80 | 10 | 32906 | 39440 | 29502171 |
| Nasopharyngitis | 19.05 | 14.80 | 23 | 32893 | 59642 | 29481969 |
| Hypersensitivity pneumonitis | 19.04 | 14.80 | 14 | 32902 | 1305 | 29540306 |
| Pulmonary sarcoidosis | 18.95 | 14.80 | 10 | 32906 | 517 | 29541094 |
| Prostate cancer | 18.68 | 14.80 | 3 | 32913 | 25524 | 29516087 |
| Autoimmune haemolytic anaemia | 18.29 | 14.80 | 22 | 32894 | 3826 | 29537785 |
| Rash maculo-papular | 18.21 | 14.80 | 64 | 32852 | 24225 | 29517386 |
| Myocardial infarction | 17.79 | 14.80 | 63 | 32853 | 110233 | 29431378 |
| Abdominal distension | 17.73 | 14.80 | 15 | 32901 | 45896 | 29495715 |
| Lymph node abscess | 17.68 | 14.80 | 4 | 32912 | 12 | 29541599 |
| Transitional cell carcinoma recurrent | 17.68 | 14.80 | 4 | 32912 | 12 | 29541599 |
| Coronary artery disease | 17.61 | 14.80 | 14 | 32902 | 44176 | 29497435 |
| Musculoskeletal stiffness | 17.43 | 14.80 | 10 | 32906 | 37448 | 29504163 |
| Overgrowth fungal | 17.41 | 14.80 | 3 | 32913 | 0 | 29541611 |
| Autoimmune cholangitis | 17.41 | 14.80 | 3 | 32913 | 0 | 29541611 |
| Diffuse uveal melanocytic proliferation | 17.41 | 14.80 | 3 | 32913 | 0 | 29541611 |
| Non-small cell lung cancer stage III | 17.41 | 14.80 | 3 | 32913 | 0 | 29541611 |
| Treatment noncompliance | 17.39 | 14.80 | 3 | 32913 | 24224 | 29517387 |
| Meningitis aseptic | 17.28 | 14.80 | 17 | 32899 | 2359 | 29539252 |
| Immune-mediated encephalopathy | 17.21 | 14.80 | 4 | 32912 | 14 | 29541597 |
| Blood bilirubin increased | 17.15 | 14.80 | 79 | 32837 | 33814 | 29507797 |
| Drug eruption | 17.03 | 14.80 | 49 | 32867 | 16692 | 29524919 |
| Immune-mediated adrenal insuficiency | 16.99 | 14.80 | 4 | 32912 | 15 | 29541596 |
| Rheumatoid nodule | 16.98 | 14.80 | 16 | 32900 | 2106 | 29539505 |
| Pyrexia | 16.90 | 14.80 | 429 | 32487 | 287193 | 29254418 |
| Angina pectoris | 16.89 | 14.80 | 5 | 32911 | 27845 | 29513766 |
| Malignant pleural effusion | 16.83 | 14.80 | 13 | 32903 | 1305 | 29540306 |
| Tumour haemorrhage | 16.64 | 14.80 | 17 | 32899 | 2468 | 29539143 |
| Adrenalitis | 16.59 | 14.80 | 4 | 32912 | 17 | 29541594 |
| Hyperhidrosis | 16.56 | 14.80 | 29 | 32887 | 64511 | 29477100 |
| Urticaria | 16.48 | 14.80 | 22 | 32894 | 54638 | 29486973 |
| Anti-thyroid antibody positive | 16.41 | 14.80 | 5 | 32911 | 58 | 29541553 |
| Metastases to skin | 16.40 | 14.80 | 8 | 32908 | 350 | 29541261 |
| Nephrolithiasis | 16.39 | 14.80 | 4 | 32912 | 25330 | 29516281 |
| Haematoma | 16.38 | 14.80 | 3 | 32913 | 23209 | 29518402 |
| Dysphagia | 16.38 | 14.80 | 111 | 32805 | 54815 | 29486796 |
| Pancreatic failure | 16.16 | 14.80 | 10 | 32906 | 701 | 29540910 |
| Limbic encephalitis | 16.11 | 14.80 | 8 | 32908 | 364 | 29541247 |
| Systemic scleroderma | 16.05 | 14.80 | 7 | 32909 | 236 | 29541375 |
| Thyroid hormones increased | 16.03 | 14.80 | 5 | 32911 | 63 | 29541548 |
| Blood corticotrophin decreased | 16.02 | 14.80 | 6 | 32910 | 135 | 29541476 |
| Heart rate decreased | 15.99 | 14.80 | 4 | 32912 | 24908 | 29516703 |
| Liver disorder | 15.79 | 14.80 | 67 | 32849 | 27682 | 29513929 |
| Dysphonia | 15.63 | 14.80 | 52 | 32864 | 19144 | 29522467 |
| Tumour ulceration | 15.23 | 14.80 | 5 | 32911 | 75 | 29541536 |
| Cardiac tamponade | 15.07 | 14.80 | 22 | 32894 | 4613 | 29536998 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 4133.99 | 14.17 | 1929 | 48756 | 110942 | 64337105 |
| Immune-mediated adverse reaction | 1204.02 | 14.17 | 241 | 50444 | 526 | 64447521 |
| Product use in unapproved indication | 711.15 | 14.17 | 781 | 49904 | 175837 | 64272210 |
| Pneumonitis | 636.85 | 14.17 | 430 | 50255 | 49935 | 64398112 |
| Immune-mediated lung disease | 596.13 | 14.17 | 147 | 50538 | 1055 | 64446992 |
| Immune-mediated enterocolitis | 558.42 | 14.17 | 165 | 50520 | 2491 | 64445556 |
| Immune-mediated hepatic disorder | 529.80 | 14.17 | 115 | 50570 | 425 | 64447622 |
| Immune-mediated hepatitis | 485.82 | 14.17 | 146 | 50539 | 2343 | 64445704 |
| Immune-mediated myocarditis | 469.02 | 14.17 | 101 | 50584 | 356 | 64447691 |
| Tumour pseudoprogression | 442.01 | 14.17 | 98 | 50587 | 409 | 64447638 |
| Interstitial lung disease | 430.92 | 14.17 | 454 | 50231 | 97278 | 64350769 |
| Colitis | 376.29 | 14.17 | 335 | 50350 | 58339 | 64389708 |
| Hypothyroidism | 372.51 | 14.17 | 285 | 50400 | 40172 | 64407875 |
| Immune-mediated hypothyroidism | 361.42 | 14.17 | 69 | 50616 | 103 | 64447944 |
| Myocarditis | 346.36 | 14.17 | 197 | 50488 | 16846 | 64431201 |
| Myasthenia gravis | 342.23 | 14.17 | 139 | 50546 | 5599 | 64442448 |
| Adrenal insufficiency | 327.83 | 14.17 | 210 | 50475 | 22277 | 64425770 |
| Death | 324.50 | 14.17 | 971 | 49714 | 481734 | 63966313 |
| Type 1 diabetes mellitus | 319.13 | 14.17 | 132 | 50553 | 5573 | 64442474 |
| Tubulointerstitial nephritis | 302.79 | 14.17 | 226 | 50459 | 30683 | 64417364 |
| Hypophysitis | 293.16 | 14.17 | 109 | 50576 | 3450 | 64444597 |
| Therapy partial responder | 268.01 | 14.17 | 140 | 50545 | 10108 | 64437939 |
| Adrenocorticotropic hormone deficiency | 255.55 | 14.17 | 70 | 50615 | 790 | 64447257 |
| Immune-mediated arthritis | 231.55 | 14.17 | 44 | 50641 | 63 | 64447984 |
| Hepatitis | 230.18 | 14.17 | 228 | 50457 | 45354 | 64402693 |
| Vitiligo | 229.59 | 14.17 | 76 | 50609 | 1692 | 64446355 |
| Off label use | 225.32 | 14.17 | 1037 | 49648 | 631769 | 63816278 |
| Myositis | 216.79 | 14.17 | 144 | 50541 | 16233 | 64431814 |
| Autoimmune hepatitis | 206.03 | 14.17 | 117 | 50568 | 9967 | 64438080 |
| Autoimmune colitis | 201.68 | 14.17 | 65 | 50620 | 1326 | 64446721 |
| Immune-mediated dermatitis | 200.93 | 14.17 | 42 | 50643 | 123 | 64447924 |
| Immune-mediated myositis | 177.46 | 14.17 | 70 | 50615 | 2608 | 64445439 |
| Hyperthyroidism | 173.71 | 14.17 | 131 | 50554 | 18048 | 64429999 |
| Thyroiditis | 173.22 | 14.17 | 75 | 50610 | 3549 | 64444498 |
| Immune-mediated thyroiditis | 159.87 | 14.17 | 33 | 50652 | 89 | 64447958 |
| Immune-mediated pancreatitis | 158.83 | 14.17 | 32 | 50653 | 73 | 64447974 |
| Autoimmune hypothyroidism | 157.28 | 14.17 | 35 | 50650 | 149 | 64447898 |
| Adverse event | 150.36 | 14.17 | 170 | 50515 | 39319 | 64408728 |
| Inappropriate schedule of product administration | 149.99 | 14.17 | 264 | 50421 | 92022 | 64356025 |
| Fulminant type 1 diabetes mellitus | 138.53 | 14.17 | 46 | 50639 | 1034 | 64447013 |
| Pemphigoid | 133.97 | 14.17 | 98 | 50587 | 12888 | 64435159 |
| Nephritis | 128.45 | 14.17 | 61 | 50624 | 3585 | 64444462 |
| Drug interaction | 122.57 | 14.17 | 66 | 50619 | 362017 | 64086030 |
| Hepatic function abnormal | 121.76 | 14.17 | 197 | 50488 | 64116 | 64383931 |
| Product use issue | 120.56 | 14.17 | 325 | 50360 | 151390 | 64296657 |
| Secondary adrenocortical insufficiency | 120.22 | 14.17 | 51 | 50634 | 2294 | 64445753 |
| Diabetic ketoacidosis | 119.64 | 14.17 | 132 | 50553 | 29713 | 64418334 |
| Tumour hyperprogression | 118.62 | 14.17 | 27 | 50658 | 130 | 64447917 |
| Autoimmune thyroiditis | 118.13 | 14.17 | 57 | 50628 | 3471 | 64444576 |
| Fall | 118.01 | 14.17 | 93 | 50592 | 416733 | 64031314 |
| Neoplasm progression | 116.27 | 14.17 | 152 | 50533 | 40812 | 64407235 |
| Immune-mediated renal disorder | 114.00 | 14.17 | 22 | 50663 | 36 | 64448011 |
| Immune-mediated gastritis | 111.82 | 14.17 | 20 | 50665 | 15 | 64448032 |
| Drug hypersensitivity | 105.98 | 14.17 | 28 | 50657 | 237787 | 64210260 |
| Headache | 103.81 | 14.17 | 160 | 50525 | 529307 | 63918740 |
| Polymyalgia rheumatica | 102.68 | 14.17 | 51 | 50634 | 3308 | 64444739 |
| Autoimmune arthritis | 96.64 | 14.17 | 22 | 50663 | 106 | 64447941 |
| Lichenoid keratosis | 94.23 | 14.17 | 48 | 50637 | 3286 | 64444761 |
| Overdose | 92.82 | 14.17 | 9 | 50676 | 159557 | 64288490 |
| Immune thrombocytopenia | 92.48 | 14.17 | 84 | 50601 | 14982 | 64433065 |
| Immune-mediated nephritis | 92.26 | 14.17 | 25 | 50660 | 270 | 64447777 |
| Hypopituitarism | 91.97 | 14.17 | 44 | 50641 | 2629 | 64445418 |
| Joint swelling | 91.07 | 14.17 | 28 | 50657 | 215354 | 64232693 |
| Cholangitis sclerosing | 86.14 | 14.17 | 38 | 50647 | 1881 | 64446166 |
| Dizziness | 84.23 | 14.17 | 130 | 50555 | 430033 | 64018014 |
| Immune-mediated endocrinopathy | 81.37 | 14.17 | 15 | 50670 | 16 | 64448031 |
| Cholangitis | 79.94 | 14.17 | 67 | 50618 | 10735 | 64437312 |
| Lymphocytic hypophysitis | 79.78 | 14.17 | 24 | 50661 | 386 | 64447661 |
| Pleural effusion | 79.20 | 14.17 | 249 | 50436 | 126310 | 64321737 |
| Nasopharyngitis | 78.49 | 14.17 | 28 | 50657 | 196045 | 64252002 |
| Drug ineffective | 75.67 | 14.17 | 372 | 50313 | 839875 | 63608172 |
| Autoimmune pancreatitis | 74.99 | 14.17 | 25 | 50660 | 569 | 64447478 |
| Toxicity to various agents | 73.91 | 14.17 | 107 | 50578 | 363406 | 64084641 |
| Myasthenic syndrome | 72.97 | 14.17 | 25 | 50660 | 620 | 64447427 |
| Hepatocellular injury | 71.62 | 14.17 | 128 | 50557 | 45107 | 64402940 |
| Injection site pain | 71.27 | 14.17 | 4 | 50681 | 111404 | 64336643 |
| Skin toxicity | 70.77 | 14.17 | 51 | 50634 | 6551 | 64441496 |
| Hypersensitivity | 70.61 | 14.17 | 33 | 50652 | 196419 | 64251628 |
| Eyelid ptosis | 70.33 | 14.17 | 59 | 50626 | 9466 | 64438581 |
| Eastern Cooperative Oncology Group performance status worsened | 70.21 | 14.17 | 29 | 50656 | 1219 | 64446828 |
| Subacute cutaneous lupus erythematosus | 69.71 | 14.17 | 38 | 50647 | 2987 | 64445060 |
| Hepatotoxicity | 69.68 | 14.17 | 118 | 50567 | 39844 | 64408203 |
| Metastases to central nervous system | 69.09 | 14.17 | 69 | 50616 | 13843 | 64434204 |
| Immune-mediated cholangitis | 67.34 | 14.17 | 16 | 50669 | 96 | 64447951 |
| Haemophagocytic lymphohistiocytosis | 67.33 | 14.17 | 76 | 50609 | 17533 | 64430514 |
| Immune-mediated hypophysitis | 66.97 | 14.17 | 14 | 50671 | 41 | 64448006 |
| Eosinophilic fasciitis | 66.80 | 14.17 | 18 | 50667 | 190 | 64447857 |
| Autoimmune myocarditis | 66.48 | 14.17 | 19 | 50666 | 253 | 64447794 |
| Decreased appetite | 65.94 | 14.17 | 412 | 50273 | 280877 | 64167170 |
| Immune-mediated encephalitis | 65.54 | 14.17 | 19 | 50666 | 267 | 64447780 |
| Drug intolerance | 63.91 | 14.17 | 34 | 50651 | 187958 | 64260089 |
| Organising pneumonia | 62.58 | 14.17 | 54 | 50631 | 9001 | 64439046 |
| Toxic epidermal necrolysis | 62.51 | 14.17 | 108 | 50577 | 37058 | 64410989 |
| Abdominal discomfort | 61.94 | 14.17 | 33 | 50652 | 182289 | 64265758 |
| Sinusitis | 61.61 | 14.17 | 19 | 50666 | 145909 | 64302138 |
| Myelosuppression | 60.84 | 14.17 | 84 | 50601 | 23746 | 64424301 |
| Pain | 59.47 | 14.17 | 229 | 50456 | 553282 | 63894765 |
| Immune-mediated hyperthyroidism | 58.79 | 14.17 | 12 | 50673 | 30 | 64448017 |
| Intentional overdose | 58.25 | 14.17 | 3 | 50682 | 89941 | 64358106 |
| Pyrexia | 57.59 | 14.17 | 681 | 50004 | 557963 | 63890084 |
| Diarrhoea | 57.45 | 14.17 | 840 | 49845 | 721864 | 63726183 |
| Autoimmune nephritis | 57.24 | 14.17 | 20 | 50665 | 527 | 64447520 |
| Condition aggravated | 55.82 | 14.17 | 132 | 50553 | 372294 | 64075753 |
| Blood thyroid stimulating hormone increased | 55.66 | 14.17 | 47 | 50638 | 7607 | 64440440 |
| Immune-mediated uveitis | 53.75 | 14.17 | 11 | 50674 | 28 | 64448019 |
| Immune-mediated cytopenia | 53.47 | 14.17 | 11 | 50674 | 29 | 64448018 |
| Transaminases increased | 53.24 | 14.17 | 112 | 50573 | 44482 | 64403565 |
| Pneumonia bacterial | 52.62 | 14.17 | 62 | 50623 | 14973 | 64433074 |
| Arthropathy | 52.43 | 14.17 | 15 | 50670 | 120952 | 64327095 |
| Pericarditis malignant | 48.99 | 14.17 | 10 | 50675 | 25 | 64448022 |
| Pericardial effusion | 48.51 | 14.17 | 100 | 50585 | 39154 | 64408893 |
| Radiation pneumonitis | 48.28 | 14.17 | 31 | 50654 | 3297 | 64444750 |
| Enteritis | 47.67 | 14.17 | 53 | 50632 | 12024 | 64436023 |
| Swelling | 47.48 | 14.17 | 34 | 50651 | 160184 | 64287863 |
| Pulmonary toxicity | 47.26 | 14.17 | 45 | 50640 | 8516 | 64439531 |
| Encephalitis autoimmune | 47.15 | 14.17 | 25 | 50660 | 1859 | 64446188 |
| Rash maculo-papular | 47.00 | 14.17 | 110 | 50575 | 46916 | 64401131 |
| Therapeutic product effect decreased | 46.95 | 14.17 | 16 | 50669 | 115335 | 64332712 |
| Respiratory failure | 46.12 | 14.17 | 249 | 50436 | 160934 | 64287113 |
| Maternal exposure during pregnancy | 45.20 | 14.17 | 10 | 50675 | 95874 | 64352173 |
| Lichen planus | 44.84 | 14.17 | 26 | 50659 | 2302 | 64445745 |
| Depression | 44.49 | 14.17 | 47 | 50638 | 183244 | 64264803 |
| Peripheral swelling | 44.00 | 14.17 | 60 | 50625 | 209093 | 64238954 |
| Silent thyroiditis | 43.36 | 14.17 | 12 | 50673 | 141 | 64447906 |
| Pain in extremity | 43.36 | 14.17 | 110 | 50575 | 302975 | 64145072 |
| Metastatic malignant melanoma | 42.73 | 14.17 | 26 | 50659 | 2515 | 64445532 |
| Contusion | 42.73 | 14.17 | 18 | 50667 | 113947 | 64334100 |
| Insomnia | 42.38 | 14.17 | 56 | 50629 | 197780 | 64250267 |
| Musculoskeletal stiffness | 42.28 | 14.17 | 22 | 50663 | 123184 | 64324863 |
| Intentional product misuse | 42.23 | 14.17 | 4 | 50681 | 72291 | 64375756 |
| Thrombocytopenia | 41.77 | 14.17 | 310 | 50375 | 223491 | 64224556 |
| Hypothalamo-pituitary disorder | 41.53 | 14.17 | 19 | 50666 | 1025 | 64447022 |
| Tumour associated fever | 41.42 | 14.17 | 16 | 50669 | 563 | 64447484 |
| Lung disorder | 41.27 | 14.17 | 123 | 50562 | 60577 | 64387470 |
| Encephalitis | 40.98 | 14.17 | 50 | 50635 | 12521 | 64435526 |
| Suicidal ideation | 40.74 | 14.17 | 3 | 50682 | 66539 | 64381508 |
| Drug effective for unapproved indication | 40.56 | 14.17 | 29 | 50656 | 3679 | 64444368 |
| Uveitis | 40.54 | 14.17 | 50 | 50635 | 12658 | 64435389 |
| Stevens-Johnson syndrome | 38.55 | 14.17 | 84 | 50601 | 34165 | 64413882 |
| Alopecia | 38.54 | 14.17 | 44 | 50641 | 165646 | 64282401 |
| Immune-mediated neuropathy | 38.38 | 14.17 | 8 | 50677 | 23 | 64448024 |
| Synovitis | 38.20 | 14.17 | 15 | 50670 | 99075 | 64348972 |
| Meningitis aseptic | 37.24 | 14.17 | 33 | 50652 | 5697 | 64442350 |
| Loss of consciousness | 37.19 | 14.17 | 37 | 50648 | 148328 | 64299719 |
| Neutropenia | 37.10 | 14.17 | 318 | 50367 | 239306 | 64208741 |
| Acute kidney injury | 37.07 | 14.17 | 526 | 50159 | 448714 | 63999333 |
| Autoimmune endocrine disorder | 36.90 | 14.17 | 6 | 50679 | 0 | 64448047 |
| Glossodynia | 36.69 | 14.17 | 4 | 50681 | 64692 | 64383355 |
| Mobility decreased | 36.54 | 14.17 | 11 | 50674 | 85829 | 64362218 |
| Blood corticotrophin decreased | 36.32 | 14.17 | 13 | 50672 | 368 | 64447679 |
| Mucosal inflammation | 36.27 | 14.17 | 120 | 50565 | 62464 | 64385583 |
| International normalised ratio increased | 35.84 | 14.17 | 9 | 50676 | 79158 | 64368889 |
| Primary hypothyroidism | 35.72 | 14.17 | 10 | 50675 | 123 | 64447924 |
| Latent autoimmune diabetes in adults | 35.63 | 14.17 | 9 | 50676 | 72 | 64447975 |
| Muscle spasms | 35.54 | 14.17 | 35 | 50650 | 140988 | 64307059 |
| Autoimmune uveitis | 35.37 | 14.17 | 7 | 50678 | 14 | 64448033 |
| Liver disorder | 35.22 | 14.17 | 107 | 50578 | 53244 | 64394803 |
| Tumour haemorrhage | 35.21 | 14.17 | 26 | 50659 | 3467 | 64444580 |
| Hospitalisation | 35.13 | 14.17 | 8 | 50677 | 75199 | 64372848 |
| Glucocorticoid deficiency | 34.98 | 14.17 | 14 | 50671 | 542 | 64447505 |
| Autoimmune haemolytic anaemia | 34.96 | 14.17 | 35 | 50650 | 7041 | 64441006 |
| Cutaneous sarcoidosis | 34.85 | 14.17 | 13 | 50672 | 415 | 64447632 |
| Guillain-Barre syndrome | 34.51 | 14.17 | 36 | 50649 | 7599 | 64440448 |
| Urticaria | 34.39 | 14.17 | 39 | 50646 | 147278 | 64300769 |
| Blood thyroid stimulating hormone abnormal | 34.22 | 14.17 | 15 | 50670 | 731 | 64447316 |
| Asthma | 34.18 | 14.17 | 16 | 50669 | 95209 | 64352838 |
| Lymphangiosis carcinomatosa | 34.18 | 14.17 | 20 | 50665 | 1801 | 64446246 |
| Weight increased | 34.05 | 14.17 | 73 | 50612 | 213275 | 64234772 |
| Ophthalmoplegia | 33.93 | 14.17 | 23 | 50662 | 2679 | 64445368 |
| Tremor | 33.79 | 14.17 | 40 | 50645 | 148190 | 64299857 |
| Paraneoplastic neurological syndrome | 33.25 | 14.17 | 8 | 50677 | 51 | 64447996 |
| Hypertransaminasaemia | 32.67 | 14.17 | 34 | 50651 | 7157 | 64440890 |
| Diabetes mellitus | 32.09 | 14.17 | 120 | 50565 | 66354 | 64381693 |
| Drug-induced liver injury | 31.87 | 14.17 | 96 | 50589 | 47547 | 64400500 |
| Discomfort | 31.58 | 14.17 | 12 | 50673 | 80866 | 64367181 |
| Pulmonary embolism | 31.54 | 14.17 | 210 | 50475 | 146146 | 64301901 |
| Cholestasis | 31.52 | 14.17 | 92 | 50593 | 44780 | 64403267 |
| Chest discomfort | 31.40 | 14.17 | 27 | 50658 | 116079 | 64331968 |
| Systemic lupus erythematosus | 31.17 | 14.17 | 11 | 50674 | 77601 | 64370446 |
| Blood pressure abnormal | 31.17 | 14.17 | 47 | 50638 | 14388 | 64433659 |
| Pulmonary sarcoidosis | 31.14 | 14.17 | 16 | 50669 | 1115 | 64446932 |
| Adrenal disorder | 30.96 | 14.17 | 18 | 50667 | 1602 | 64446445 |
| Wound | 30.44 | 14.17 | 11 | 50674 | 76466 | 64371581 |
| Bradycardia | 30.18 | 14.17 | 29 | 50656 | 118190 | 64329857 |
| Malignant pleural effusion | 29.72 | 14.17 | 22 | 50663 | 2945 | 64445102 |
| Loss of personal independence in daily activities | 29.57 | 14.17 | 10 | 50675 | 72444 | 64375603 |
| Cardiac failure congestive | 28.95 | 14.17 | 36 | 50649 | 130544 | 64317503 |
| Serous retinal detachment | 28.70 | 14.17 | 13 | 50672 | 685 | 64447362 |
| Blood cholesterol increased | 28.64 | 14.17 | 3 | 50682 | 50063 | 64397984 |
| Cancer pain | 28.63 | 14.17 | 25 | 50660 | 4232 | 64443815 |
| Migraine | 28.61 | 14.17 | 7 | 50678 | 62670 | 64385377 |
| Palmar-plantar erythrodysaesthesia syndrome | 28.34 | 14.17 | 67 | 50618 | 28752 | 64419295 |
| Coma | 28.10 | 14.17 | 17 | 50668 | 87598 | 64360449 |
| Immune-mediated encephalopathy | 27.89 | 14.17 | 6 | 50679 | 21 | 64448026 |
| Rash | 27.72 | 14.17 | 510 | 50175 | 458039 | 63990008 |
| Melanoma recurrent | 27.63 | 14.17 | 9 | 50676 | 190 | 64447857 |
| Bronchitis | 27.38 | 14.17 | 27 | 50658 | 108716 | 64339331 |
| Stress | 27.17 | 14.17 | 7 | 50678 | 60527 | 64387520 |
| Renal tubular necrosis | 26.93 | 14.17 | 56 | 50629 | 22054 | 64425993 |
| Mixed liver injury | 26.87 | 14.17 | 27 | 50658 | 5454 | 64442593 |
| Adrenalitis | 26.51 | 14.17 | 6 | 50679 | 28 | 64448019 |
| Unevaluable event | 26.51 | 14.17 | 4 | 50681 | 50485 | 64397562 |
| Hypotension | 26.44 | 14.17 | 183 | 50502 | 380791 | 64067256 |
| Cardiac arrest | 26.03 | 14.17 | 51 | 50634 | 154013 | 64294034 |
| Optic neuritis | 26.00 | 14.17 | 32 | 50653 | 8084 | 64439963 |
| Syncope | 25.93 | 14.17 | 53 | 50632 | 157582 | 64290465 |
| Aggression | 25.86 | 14.17 | 3 | 50682 | 46229 | 64401818 |
| Agitation | 25.84 | 14.17 | 19 | 50666 | 88348 | 64359699 |
| Myasthenia gravis crisis | 25.78 | 14.17 | 13 | 50672 | 871 | 64447176 |
| Cytokine release syndrome | 25.65 | 14.17 | 53 | 50632 | 20776 | 64427271 |
| Pneumothorax | 25.55 | 14.17 | 58 | 50627 | 24240 | 64423807 |
| Autoimmune disorder | 25.53 | 14.17 | 27 | 50658 | 5789 | 64442258 |
| Haemoglobin decreased | 25.46 | 14.17 | 74 | 50611 | 194989 | 64253058 |
| Amputation stump pain | 25.11 | 14.17 | 6 | 50679 | 37 | 64448010 |
| Influenza | 25.08 | 14.17 | 28 | 50657 | 106503 | 64341544 |
| Hallucination | 24.96 | 14.17 | 13 | 50672 | 72775 | 64375272 |
| Immunisation reaction | 24.84 | 14.17 | 6 | 50679 | 39 | 64448008 |
| Nasal congestion | 24.75 | 14.17 | 8 | 50677 | 59650 | 64388397 |
| Pancreatic failure | 24.71 | 14.17 | 15 | 50670 | 1445 | 64446602 |
| Diffuse uveal melanocytic proliferation | 24.60 | 14.17 | 4 | 50681 | 0 | 64448047 |
| Immune-mediated neurological disorder | 24.60 | 14.17 | 4 | 50681 | 0 | 64448047 |
| Autoimmune dermatitis | 24.45 | 14.17 | 6 | 50679 | 42 | 64448005 |
| Polyarthritis | 24.43 | 14.17 | 34 | 50651 | 9681 | 64438366 |
| Heart rate increased | 24.27 | 14.17 | 25 | 50660 | 98650 | 64349397 |
| Cardiac tamponade | 24.26 | 14.17 | 31 | 50654 | 8133 | 64439914 |
| Hepatitis toxic | 24.04 | 14.17 | 23 | 50662 | 4377 | 64443670 |
| Tumour pain | 23.19 | 14.17 | 16 | 50669 | 1917 | 64446130 |
| Immune-mediated adrenal insuficiency | 23.13 | 14.17 | 5 | 50680 | 18 | 64448029 |
| Neurofibrosarcoma | 23.10 | 14.17 | 8 | 50677 | 205 | 64447842 |
| Atrioventricular block complete | 23.07 | 14.17 | 41 | 50644 | 14377 | 64433670 |
| Amylase increased | 23.03 | 14.17 | 33 | 50652 | 9652 | 64438395 |
| Large intestine perforation | 23.01 | 14.17 | 38 | 50647 | 12566 | 64435481 |
| Thyroid hormones increased | 22.77 | 14.17 | 9 | 50676 | 337 | 64447710 |
| Thyroid disorder | 22.36 | 14.17 | 36 | 50649 | 11656 | 64436391 |
| Dermatitis | 22.35 | 14.17 | 46 | 50639 | 17983 | 64430064 |
| EGFR gene mutation | 22.33 | 14.17 | 9 | 50676 | 355 | 64447692 |
| Duodenitis | 22.28 | 14.17 | 27 | 50658 | 6714 | 64441333 |
| Blood bilirubin increased | 22.27 | 14.17 | 97 | 50588 | 57456 | 64390591 |
| Dysphagia | 22.24 | 14.17 | 152 | 50533 | 106660 | 64341387 |
| Anxiety | 22.22 | 14.17 | 83 | 50602 | 202566 | 64245481 |
| Electrocardiogram QT prolonged | 22.07 | 14.17 | 18 | 50667 | 79430 | 64368617 |
| Aspartate aminotransferase increased | 21.79 | 14.17 | 165 | 50520 | 119623 | 64328424 |
| Heart rate decreased | 21.78 | 14.17 | 8 | 50677 | 55059 | 64392988 |
| Thyroid function test abnormal | 21.60 | 14.17 | 18 | 50667 | 2861 | 64445186 |
| Pulmonary granuloma | 21.55 | 14.17 | 15 | 50670 | 1824 | 64446223 |
| Haematoma | 21.44 | 14.17 | 5 | 50680 | 46245 | 64401802 |
| Therapeutic product effect incomplete | 21.43 | 14.17 | 30 | 50655 | 103452 | 64344595 |
| Hyperhidrosis | 21.40 | 14.17 | 41 | 50644 | 124879 | 64323168 |
| Cachexia | 21.32 | 14.17 | 31 | 50654 | 9186 | 64438861 |
| Vanishing bile duct syndrome | 21.30 | 14.17 | 13 | 50672 | 1264 | 64446783 |
| Adrenocortical insufficiency acute | 21.27 | 14.17 | 17 | 50668 | 2548 | 64445499 |
| Alanine aminotransferase increased | 21.22 | 14.17 | 184 | 50501 | 138847 | 64309200 |
| Oligodipsia | 21.19 | 14.17 | 5 | 50680 | 29 | 64448018 |
| Small intestinal perforation | 21.18 | 14.17 | 17 | 50668 | 2563 | 64445484 |
| Palpitations | 20.94 | 14.17 | 31 | 50654 | 104457 | 64343590 |
| Autoimmune neuropathy | 20.92 | 14.17 | 6 | 50679 | 81 | 64447966 |
| Upper respiratory tract infection | 20.83 | 14.17 | 16 | 50669 | 72769 | 64375278 |
| Radiation associated pain | 20.78 | 14.17 | 6 | 50679 | 83 | 64447964 |
| Taste disorder | 20.77 | 14.17 | 31 | 50654 | 9402 | 64438645 |
| Vital functions abnormal | 20.75 | 14.17 | 10 | 50675 | 607 | 64447440 |
| Blood thyroid stimulating hormone decreased | 20.72 | 14.17 | 23 | 50662 | 5207 | 64442840 |
| Osteoarthritis | 20.72 | 14.17 | 12 | 50673 | 63324 | 64384723 |
| Gait disturbance | 20.55 | 14.17 | 68 | 50617 | 172087 | 64275960 |
| Gastrooesophageal reflux disease | 20.52 | 14.17 | 21 | 50664 | 83122 | 64364925 |
| Autoimmune encephalopathy | 20.46 | 14.17 | 6 | 50679 | 88 | 64447959 |
| Cortisol decreased | 20.40 | 14.17 | 14 | 50671 | 1663 | 64446384 |
| Enterocolitis | 20.30 | 14.17 | 35 | 50650 | 11983 | 64436064 |
| Renal impairment | 20.25 | 14.17 | 178 | 50507 | 134839 | 64313208 |
| Hypoaesthesia | 20.24 | 14.17 | 50 | 50635 | 139058 | 64308989 |
| Autoimmune cholangitis | 20.21 | 14.17 | 4 | 50681 | 8 | 64448039 |
| Burning sensation | 20.01 | 14.17 | 7 | 50678 | 49657 | 64398390 |
| Tumour ulceration | 19.91 | 14.17 | 7 | 50678 | 188 | 64447859 |
| Hypersensitivity pneumonitis | 19.79 | 14.17 | 18 | 50667 | 3214 | 64444833 |
| Anaphylactic reaction | 19.77 | 14.17 | 15 | 50670 | 68649 | 64379398 |
| Paraneoplastic syndrome | 19.75 | 14.17 | 11 | 50674 | 902 | 64447145 |
| BRAF V600E mutation positive | 19.68 | 14.17 | 5 | 50680 | 41 | 64448006 |
| Depressed level of consciousness | 19.61 | 14.17 | 21 | 50664 | 81415 | 64366632 |
| Rheumatoid arthritis | 19.54 | 14.17 | 65 | 50620 | 164229 | 64283818 |
| Pancytopenia | 19.50 | 14.17 | 185 | 50500 | 143124 | 64304923 |
| Sarcoidosis | 19.31 | 14.17 | 24 | 50661 | 6122 | 64441925 |
| Haemoptysis | 19.23 | 14.17 | 83 | 50602 | 48965 | 64399082 |
| Systemic scleroderma | 19.20 | 14.17 | 11 | 50674 | 952 | 64447095 |
| Feeling hot | 19.16 | 14.17 | 6 | 50679 | 45657 | 64402390 |
| Transitional cell carcinoma recurrent | 19.06 | 14.17 | 4 | 50681 | 12 | 64448035 |
| Impaired healing | 19.02 | 14.17 | 12 | 50673 | 60461 | 64387586 |
| Wrong technique in product usage process | 18.96 | 14.17 | 14 | 50671 | 64960 | 64383087 |
| Drug eruption | 18.93 | 14.17 | 67 | 50618 | 36069 | 64411978 |
| Respiratory arrest | 18.86 | 14.17 | 9 | 50676 | 52976 | 64395071 |
| Serotonin syndrome | 18.70 | 14.17 | 4 | 50681 | 39278 | 64408769 |
| General physical health deterioration | 18.70 | 14.17 | 244 | 50441 | 204181 | 64243866 |
| Colitis microscopic | 18.67 | 14.17 | 26 | 50659 | 7406 | 64440641 |
| Bacterial diarrhoea | 18.63 | 14.17 | 6 | 50679 | 122 | 64447925 |
| Cholecystitis | 18.60 | 14.17 | 45 | 50640 | 19591 | 64428456 |
| Primary biliary cholangitis | 18.60 | 14.17 | 11 | 50674 | 1010 | 64447037 |
| Fluid retention | 18.51 | 14.17 | 12 | 50673 | 59594 | 64388453 |
| Gastrointestinal tube removal | 18.45 | 14.17 | 3 | 50682 | 0 | 64448047 |
| Swelling face | 18.25 | 14.17 | 12 | 50673 | 59154 | 64388893 |
| Blood pressure systolic increased | 18.23 | 14.17 | 8 | 50677 | 49445 | 64398602 |
| Lactic acidosis | 18.22 | 14.17 | 13 | 50672 | 61397 | 64386650 |
| Oropharyngeal pain | 18.17 | 14.17 | 26 | 50659 | 88841 | 64359206 |
| Ageusia | 18.02 | 14.17 | 36 | 50649 | 13777 | 64434270 |
| Multiple sclerosis relapse | 18 | 14.17 | 5 | 50680 | 41130 | 64406917 |
| Granulocyte count increased | 18.00 | 14.17 | 10 | 50675 | 816 | 64447231 |
| Dermatomyositis | 17.92 | 14.17 | 16 | 50669 | 2790 | 64445257 |
| Pain in jaw | 17.75 | 14.17 | 5 | 50680 | 40750 | 64407297 |
| Rash morbilliform | 17.66 | 14.17 | 21 | 50664 | 5120 | 64442927 |
| Cheilitis | 17.63 | 14.17 | 20 | 50665 | 4636 | 64443411 |
| Paraesthesia | 17.57 | 14.17 | 51 | 50634 | 134471 | 64313576 |
| Intentional product use issue | 17.50 | 14.17 | 30 | 50655 | 95334 | 64352713 |
| Myocardial infarction | 17.48 | 14.17 | 69 | 50616 | 165752 | 64282295 |
| Antinuclear antibody | 17.31 | 14.17 | 8 | 50677 | 442 | 64447605 |
| Somnolence | 17.15 | 14.17 | 92 | 50593 | 203553 | 64244494 |
| Abdominal pain upper | 17.10 | 14.17 | 75 | 50610 | 174955 | 64273092 |
| Angina pectoris | 17.08 | 14.17 | 7 | 50678 | 45074 | 64402973 |
| Lymphadenopathy mediastinal | 17.03 | 14.17 | 18 | 50667 | 3858 | 64444189 |
| Infusion related reaction | 16.98 | 14.17 | 69 | 50616 | 164398 | 64283649 |
| Keratoacanthoma | 16.97 | 14.17 | 10 | 50675 | 912 | 64447135 |
| Abdominal distension | 16.89 | 14.17 | 31 | 50654 | 95963 | 64352084 |
| Dyskinesia | 16.84 | 14.17 | 5 | 50680 | 39383 | 64408664 |
| Neutrophil count decreased | 16.75 | 14.17 | 111 | 50574 | 77085 | 64370962 |
| Autoimmune myositis | 16.47 | 14.17 | 6 | 50679 | 179 | 64447868 |
| Radiation necrosis | 16.29 | 14.17 | 7 | 50678 | 325 | 64447722 |
| Lung opacity | 16.13 | 14.17 | 16 | 50669 | 3183 | 64444864 |
| Acquired gene mutation | 16.12 | 14.17 | 13 | 50672 | 1973 | 64446074 |
| Treatment noncompliance | 16.08 | 14.17 | 7 | 50678 | 43475 | 64404572 |
| Chronic gastritis | 15.96 | 14.17 | 16 | 50669 | 3224 | 64444823 |
| Polyglandular autoimmune syndrome type II | 15.95 | 14.17 | 4 | 50681 | 31 | 64448016 |
| Cardiomyopathy | 15.94 | 14.17 | 50 | 50635 | 25306 | 64422741 |
| Urogenital fistula | 15.89 | 14.17 | 5 | 50680 | 94 | 64447953 |
| Pulmonary hypertension | 15.87 | 14.17 | 7 | 50678 | 43132 | 64404915 |
| Lipase increased | 15.84 | 14.17 | 35 | 50650 | 14367 | 64433680 |
| Vogt-Koyanagi-Harada disease | 15.75 | 14.17 | 6 | 50679 | 203 | 64447844 |
| Tumour rupture | 15.73 | 14.17 | 7 | 50678 | 354 | 64447693 |
| Infectious pleural effusion | 15.71 | 14.17 | 15 | 50670 | 2847 | 64445200 |
| Circumstance or information capable of leading to medication error | 15.55 | 14.17 | 16 | 50669 | 3324 | 64444723 |
| Adenocarcinoma | 15.51 | 14.17 | 16 | 50669 | 3335 | 64444712 |
| Treatment failure | 15.46 | 14.17 | 44 | 50641 | 116772 | 64331275 |
| Restlessness | 15.37 | 14.17 | 6 | 50679 | 39779 | 64408268 |
| Troponin increased | 15.36 | 14.17 | 36 | 50649 | 15363 | 64432684 |
| Acute polyneuropathy | 15.29 | 14.17 | 7 | 50678 | 378 | 64447669 |
| Hepatic cytolysis | 15.29 | 14.17 | 34 | 50651 | 14015 | 64434032 |
| Rash pruritic | 15.27 | 14.17 | 87 | 50598 | 57317 | 64390730 |
| Dermatitis psoriasiform | 15.24 | 14.17 | 13 | 50672 | 2133 | 64445914 |
| Neuritis cranial | 15.16 | 14.17 | 3 | 50682 | 6 | 64448041 |
| Stoma site dermatitis | 15.16 | 14.17 | 3 | 50682 | 6 | 64448041 |
| Weight fluctuation | 15.16 | 14.17 | 25 | 50660 | 8257 | 64439790 |
| Disorientation | 15.07 | 14.17 | 13 | 50672 | 55815 | 64392232 |
| Parathyroid tumour malignant | 15.04 | 14.17 | 4 | 50681 | 40 | 64448007 |
| Morphoea | 14.94 | 14.17 | 7 | 50678 | 399 | 64447648 |
| Scleroderma-like reaction | 14.87 | 14.17 | 5 | 50680 | 117 | 64447930 |
| Sedation | 14.82 | 14.17 | 7 | 50678 | 41455 | 64406592 |
| Nephrolithiasis | 14.68 | 14.17 | 8 | 50677 | 43675 | 64404372 |
| Hyperglycaemia | 14.67 | 14.17 | 90 | 50595 | 60878 | 64387169 |
| Lower respiratory tract infection | 14.56 | 14.17 | 33 | 50652 | 94581 | 64353466 |
| Melanosis | 14.53 | 14.17 | 4 | 50681 | 46 | 64448001 |
| Dry mouth | 14.42 | 14.17 | 89 | 50596 | 60329 | 64387718 |
| Intestinal perforation | 14.41 | 14.17 | 35 | 50650 | 15278 | 64432769 |
| Infusion site haemorrhage | 14.39 | 14.17 | 13 | 50672 | 2302 | 64445745 |
| Ketoacidosis | 14.33 | 14.17 | 22 | 50663 | 6841 | 64441206 |
| Lymph node abscess | 14.30 | 14.17 | 4 | 50681 | 49 | 64447998 |
| Limbic encephalitis | 14.28 | 14.17 | 8 | 50677 | 663 | 64447384 |
| Seizure | 14.27 | 14.17 | 75 | 50610 | 166817 | 64281230 |
| Metabolic acidosis | 14.27 | 14.17 | 21 | 50664 | 70937 | 64377110 |
| Product quality issue | 14.26 | 14.17 | 3 | 50682 | 29796 | 64418251 |
| Wheezing | 14.19 | 14.17 | 26 | 50659 | 80553 | 64367494 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L01FF02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| MeSH PA | D000082082 | Immune Checkpoint Inhibitors |
| FDA MoA | N0000191259 | Programmed Death Receptor-1-directed Antibody Interactions |
| FDA EPC | N0000191260 | Programmed Death Receptor-1 Blocking Antibody |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Unresectable urothelial carcinoma | indication | 27090000 | DOID:2671 |
| Non-small cell lung cancer | indication | 254637007 | DOID:3908 |
| Endometrial carcinoma progressing after chemotherapy | indication | 254878006 | DOID:2871 |
| Malignant tumor of head and/or neck | indication | 255056009 | |
| Squamous cell carcinoma of esophagus | indication | 276804009 | DOID:3748 |
| Metastatic malignant melanoma | indication | 443493003 | |
| Metastatic renal cell carcinoma | indication | 702392008 | |
| Triple negative breast neoplasms | indication | 706970001 | |
| Microsatellite instability-high colorectal cancer | indication | 737058005 | |
| Classical Hodgkin lymphoma | indication | 762690000 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Programmed cell death protein 1 | Membrane receptor | ANTIBODY BINDING | Kd | 10 | IUPHAR | DRUG LABEL |
| ID | Source |
|---|---|
| D10574 | KEGG_DRUG |
| 4033703 | VUID |
| N0000191088 | NUI |
| 4033703 | VANDF |
| CHEMBL3137343 | ChEMBL_ID |
| C582435 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7499 | IUPHAR_LIGAND_ID |
| 9798 | INN_ID |
| DB09037 | DRUGBANK_ID |
| DPT0O3T46P | UNII |
| 1547545 | RXNORM |
| 228586 | MMSL |
| 30533 | MMSL |
| d08287 | MMSL |
| 015666 | NDDF |
| 716125002 | SNOMEDCT_US |
| 763541003 | SNOMEDCT_US |
| C3658706 | UMLSCUI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3026 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | BLA | 29 sections |
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3026 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | BLA | 29 sections |
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3026 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | BLA | 29 sections |
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3029 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 mg | INTRAVENOUS | BLA | 29 sections |
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3029 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 mg | INTRAVENOUS | BLA | 29 sections |
| KEYTRUDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3029 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 mg | INTRAVENOUS | BLA | 29 sections |