| 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 | 1916.13 | 15.97 | 803 | 20570 | 70738 | 53256955 |
| Product use in unapproved indication | 635.16 | 15.97 | 450 | 20923 | 111839 | 53215854 |
| Immune-mediated adverse reaction | 495.24 | 15.97 | 86 | 21287 | 164 | 53327529 |
| Immune-mediated lung disease | 283.10 | 15.97 | 56 | 21317 | 273 | 53327420 |
| Pneumonitis | 280.53 | 15.97 | 167 | 21206 | 30721 | 53296972 |
| Immune-mediated hepatitis | 239.73 | 15.97 | 58 | 21315 | 802 | 53326891 |
| Immune-mediated enterocolitis | 218.19 | 15.97 | 55 | 21318 | 909 | 53326784 |
| Colitis | 216.94 | 15.97 | 159 | 21214 | 41393 | 53286300 |
| Hypothyroidism | 206.40 | 15.97 | 146 | 21227 | 35961 | 53291732 |
| Tumour pseudoprogression | 192.48 | 15.97 | 38 | 21335 | 183 | 53327510 |
| Tubulointerstitial nephritis | 181.17 | 15.97 | 101 | 21272 | 16403 | 53311290 |
| Hepatitis | 179.84 | 15.97 | 131 | 21242 | 33763 | 53293930 |
| Myocarditis | 173.21 | 15.97 | 79 | 21294 | 8389 | 53319304 |
| Hypophysitis | 149.95 | 15.97 | 46 | 21327 | 1601 | 53326092 |
| Immune-mediated hypothyroidism | 148.16 | 15.97 | 24 | 21349 | 22 | 53327671 |
| Death | 146.54 | 15.97 | 391 | 20982 | 356841 | 52970852 |
| Autoimmune colitis | 130.84 | 15.97 | 32 | 21341 | 464 | 53327229 |
| Immune-mediated hepatic disorder | 130.27 | 15.97 | 24 | 21349 | 73 | 53327620 |
| Type 1 diabetes mellitus | 125.47 | 15.97 | 48 | 21325 | 3275 | 53324418 |
| Thyroiditis | 124.06 | 15.97 | 41 | 21332 | 1821 | 53325872 |
| Immune-mediated myocarditis | 117.73 | 15.97 | 21 | 21352 | 50 | 53327643 |
| Autoimmune hypothyroidism | 112.65 | 15.97 | 22 | 21351 | 99 | 53327594 |
| Vitiligo | 109.96 | 15.97 | 34 | 21339 | 1215 | 53326478 |
| Off label use | 108.67 | 15.97 | 424 | 20949 | 471788 | 52855905 |
| Lichenoid keratosis | 107.78 | 15.97 | 35 | 21338 | 1470 | 53326223 |
| Adverse event | 106.27 | 15.97 | 105 | 21268 | 40956 | 53286737 |
| Adrenal insufficiency | 103.79 | 15.97 | 68 | 21305 | 14761 | 53312932 |
| Fulminant type 1 diabetes mellitus | 96.50 | 15.97 | 23 | 21350 | 297 | 53327396 |
| Immune-mediated thyroiditis | 95.75 | 15.97 | 17 | 21356 | 39 | 53327654 |
| Immune-mediated dermatitis | 91.96 | 15.97 | 15 | 21358 | 15 | 53327678 |
| Hyperthyroidism | 91.62 | 15.97 | 60 | 21313 | 13013 | 53314680 |
| Adrenocorticotropic hormone deficiency | 89.45 | 15.97 | 21 | 21352 | 253 | 53327440 |
| Product use issue | 89.07 | 15.97 | 182 | 21191 | 139402 | 53188291 |
| Autoimmune hepatitis | 88.80 | 15.97 | 50 | 21323 | 8268 | 53319425 |
| Nephritis | 87.53 | 15.97 | 33 | 21340 | 2162 | 53325531 |
| Therapy partial responder | 85.25 | 15.97 | 44 | 21329 | 6119 | 53321574 |
| Immune-mediated arthritis | 83.96 | 15.97 | 14 | 21359 | 18 | 53327675 |
| Immune-mediated pancreatitis | 80.37 | 15.97 | 15 | 21358 | 50 | 53327643 |
| Autoimmune thyroiditis | 77.64 | 15.97 | 34 | 21339 | 3277 | 53324416 |
| Myasthenia gravis | 75.30 | 15.97 | 35 | 21338 | 3878 | 53323815 |
| Myositis | 72.12 | 15.97 | 44 | 21329 | 8439 | 53319254 |
| Drug hypersensitivity | 66.15 | 15.97 | 13 | 21360 | 265229 | 53062464 |
| Metastatic malignant melanoma | 64.80 | 15.97 | 24 | 21349 | 1496 | 53326197 |
| Inappropriate schedule of product administration | 61.78 | 15.97 | 109 | 21264 | 74769 | 53252924 |
| Immune-mediated gastritis | 61.41 | 15.97 | 9 | 21364 | 0 | 53327693 |
| Rheumatoid arthritis | 56.12 | 15.97 | 28 | 21345 | 314503 | 53013190 |
| Drug ineffective | 55.71 | 15.97 | 157 | 21216 | 817088 | 52510605 |
| Cholestasis | 52.36 | 15.97 | 61 | 21312 | 28634 | 53299059 |
| Diabetic ketoacidosis | 51.63 | 15.97 | 51 | 21322 | 19864 | 53307829 |
| Fall | 51.46 | 15.97 | 41 | 21332 | 358399 | 52969294 |
| Neoplasm progression | 50.30 | 15.97 | 61 | 21312 | 29858 | 53297835 |
| Renal tubular necrosis | 49.18 | 15.97 | 39 | 21334 | 11380 | 53316313 |
| Hepatic function abnormal | 49.10 | 15.97 | 67 | 21306 | 36832 | 53290861 |
| Immune-mediated nephritis | 48.94 | 15.97 | 10 | 21363 | 59 | 53327634 |
| Autoimmune arthritis | 48.22 | 15.97 | 9 | 21364 | 30 | 53327663 |
| Immune-mediated endocrinopathy | 47.76 | 15.97 | 7 | 21366 | 0 | 53327693 |
| Secondary adrenocortical insufficiency | 46.76 | 15.97 | 18 | 21355 | 1248 | 53326445 |
| Nasopharyngitis | 46.73 | 15.97 | 10 | 21363 | 192285 | 53135408 |
| Joint swelling | 46.39 | 15.97 | 18 | 21355 | 234620 | 53093073 |
| Immune-mediated hyperthyroidism | 46.14 | 15.97 | 8 | 21365 | 15 | 53327678 |
| Uveitis | 46.02 | 15.97 | 35 | 21338 | 9609 | 53318084 |
| Metastases to central nervous system | 45.24 | 15.97 | 38 | 21335 | 12019 | 53315674 |
| Drug effective for unapproved indication | 44.87 | 15.97 | 20 | 21353 | 2010 | 53325683 |
| Lichen planus | 44.46 | 15.97 | 20 | 21353 | 2054 | 53325639 |
| Hypopituitarism | 44.32 | 15.97 | 16 | 21357 | 927 | 53326766 |
| Hepatotoxicity | 43.89 | 15.97 | 55 | 21318 | 27825 | 53299868 |
| Interstitial lung disease | 42.85 | 15.97 | 81 | 21292 | 58541 | 53269152 |
| Lymphocytic hypophysitis | 42.80 | 15.97 | 11 | 21362 | 197 | 53327496 |
| Polymyalgia rheumatica | 41.95 | 15.97 | 21 | 21352 | 2738 | 53324955 |
| Pemphigoid | 41.34 | 15.97 | 28 | 21345 | 6416 | 53321277 |
| Dizziness | 40.49 | 15.97 | 54 | 21319 | 372205 | 52955488 |
| Sinusitis | 40.47 | 15.97 | 9 | 21364 | 168555 | 53159138 |
| Autoimmune pancreatitis | 39.83 | 15.97 | 11 | 21362 | 262 | 53327431 |
| Hepatocellular injury | 39.22 | 15.97 | 54 | 21319 | 29932 | 53297761 |
| Blood thyroid stimulating hormone increased | 38.95 | 15.97 | 27 | 21346 | 6425 | 53321268 |
| Abdominal discomfort | 38.91 | 15.97 | 20 | 21353 | 221042 | 53106651 |
| Subacute cutaneous lupus erythematosus | 38.90 | 15.97 | 19 | 21354 | 2349 | 53325344 |
| Exposure during pregnancy | 38.63 | 15.97 | 3 | 21370 | 124857 | 53202836 |
| Immune-mediated myositis | 38.28 | 15.97 | 15 | 21358 | 1091 | 53326602 |
| Pyrexia | 37.57 | 15.97 | 283 | 21090 | 402910 | 52924783 |
| Autoimmune nephritis | 37.22 | 15.97 | 11 | 21362 | 336 | 53327357 |
| Drug intolerance | 37.06 | 15.97 | 18 | 21355 | 205475 | 53122218 |
| Hypersensitivity | 34.28 | 15.97 | 21 | 21352 | 210644 | 53117049 |
| Skin toxicity | 34.20 | 15.97 | 21 | 21352 | 4072 | 53323621 |
| Hepatitis toxic | 33.84 | 15.97 | 19 | 21354 | 3122 | 53324571 |
| Tumour hyperprogression | 33.80 | 15.97 | 8 | 21365 | 100 | 53327593 |
| Eosinophilic fasciitis | 33.51 | 15.97 | 8 | 21365 | 104 | 53327589 |
| Condition aggravated | 33.42 | 15.97 | 42 | 21331 | 297092 | 53030601 |
| Transaminases increased | 33.16 | 15.97 | 50 | 21323 | 30082 | 53297611 |
| Headache | 32.94 | 15.97 | 108 | 21265 | 536713 | 52790980 |
| Autoimmune myocarditis | 32.86 | 15.97 | 7 | 21366 | 52 | 53327641 |
| Immune-mediated neuropathy | 31.77 | 15.97 | 5 | 21368 | 3 | 53327690 |
| Drug interaction | 31.54 | 15.97 | 25 | 21348 | 219304 | 53108389 |
| Myasthenic syndrome | 31.48 | 15.97 | 9 | 21364 | 244 | 53327449 |
| Swelling | 31.16 | 15.97 | 19 | 21354 | 191086 | 53136607 |
| Eastern Cooperative Oncology Group performance status worsened | 30.67 | 15.97 | 11 | 21362 | 625 | 53327068 |
| Neurofibrosarcoma | 30.58 | 15.97 | 8 | 21365 | 154 | 53327539 |
| Cholangitis sclerosing | 30.44 | 15.97 | 13 | 21360 | 1178 | 53326515 |
| Amputation stump pain | 30.04 | 15.97 | 6 | 21367 | 31 | 53327662 |
| Rash maculo-papular | 29.44 | 15.97 | 47 | 21326 | 29702 | 53297991 |
| Toxic epidermal necrolysis | 28.69 | 15.97 | 41 | 21332 | 23509 | 53304184 |
| Immune-mediated hypophysitis | 28.30 | 15.97 | 5 | 21368 | 11 | 53327682 |
| Polyglandular autoimmune syndrome type II | 28.23 | 15.97 | 6 | 21367 | 44 | 53327649 |
| Acute kidney injury | 28.15 | 15.97 | 186 | 21187 | 253682 | 53074011 |
| Tumour associated fever | 27.91 | 15.97 | 8 | 21365 | 219 | 53327474 |
| Therapeutic product effect decreased | 27.67 | 15.97 | 8 | 21365 | 125647 | 53202046 |
| Autoimmune dermatitis | 27.56 | 15.97 | 6 | 21367 | 50 | 53327643 |
| Maternal exposure during pregnancy | 27.50 | 15.97 | 14 | 21359 | 155625 | 53172068 |
| Overdose | 27.42 | 15.97 | 5 | 21368 | 107731 | 53219962 |
| Autoimmune endocrine disorder | 27.29 | 15.97 | 4 | 21369 | 0 | 53327693 |
| Glossodynia | 26.98 | 15.97 | 4 | 21369 | 100287 | 53227406 |
| Glucocorticoid deficiency | 26.96 | 15.97 | 8 | 21365 | 248 | 53327445 |
| Pain | 26.86 | 15.97 | 133 | 21240 | 588265 | 52739428 |
| Alopecia | 26.53 | 15.97 | 33 | 21340 | 234550 | 53093143 |
| Immune-mediated encephalitis | 26.14 | 15.97 | 6 | 21367 | 65 | 53327628 |
| Arthropathy | 26.09 | 15.97 | 12 | 21361 | 141441 | 53186252 |
| Immune-mediated cholangitis | 26.08 | 15.97 | 5 | 21368 | 20 | 53327673 |
| Thyroid hormones increased | 25.84 | 15.97 | 8 | 21365 | 287 | 53327406 |
| Oligodipsia | 25.34 | 15.97 | 5 | 21368 | 24 | 53327669 |
| Metastases to adrenals | 25.31 | 15.97 | 10 | 21363 | 743 | 53326950 |
| Cytokine release syndrome | 25.23 | 15.97 | 23 | 21350 | 8106 | 53319587 |
| Neutropenia | 25.05 | 15.97 | 128 | 21245 | 159057 | 53168636 |
| Bronchitis | 24.86 | 15.97 | 7 | 21366 | 111892 | 53215801 |
| Rash pruritic | 24.79 | 15.97 | 59 | 21314 | 49951 | 53277742 |
| Decreased appetite | 24.73 | 15.97 | 159 | 21214 | 214815 | 53112878 |
| Duodenitis | 24.36 | 15.97 | 16 | 21357 | 3483 | 53324210 |
| Cutaneous sarcoidosis | 23.89 | 15.97 | 8 | 21365 | 370 | 53327323 |
| Asthma | 23.88 | 15.97 | 7 | 21366 | 108965 | 53218728 |
| Aspartate aminotransferase increased | 23.84 | 15.97 | 81 | 21292 | 83948 | 53243745 |
| Neonatal respiratory depression | 23.58 | 15.97 | 6 | 21367 | 103 | 53327590 |
| Synovitis | 23.51 | 15.97 | 7 | 21366 | 107886 | 53219807 |
| Pulmonary embolism | 23.12 | 15.97 | 99 | 21274 | 114343 | 53213350 |
| Discomfort | 23.10 | 15.97 | 5 | 21368 | 95467 | 53232226 |
| Pericardial effusion | 22.85 | 15.97 | 40 | 21333 | 27238 | 53300455 |
| Liver disorder | 22.81 | 15.97 | 50 | 21323 | 40105 | 53287588 |
| Diarrhoea | 22.78 | 15.97 | 364 | 21009 | 625182 | 52702511 |
| Radiation pneumonitis | 22.76 | 15.97 | 11 | 21362 | 1329 | 53326364 |
| BRAF V600E mutation positive | 22.24 | 15.97 | 5 | 21368 | 49 | 53327644 |
| Thyroid disorder | 21.88 | 15.97 | 27 | 21346 | 13446 | 53314247 |
| Wound | 21.74 | 15.97 | 5 | 21368 | 91552 | 53236141 |
| Toxicity to various agents | 21.72 | 15.97 | 34 | 21339 | 219564 | 53108129 |
| Thrombocytopenia | 21.43 | 15.97 | 111 | 21262 | 138616 | 53189077 |
| Pleural effusion | 21.38 | 15.97 | 81 | 21292 | 88498 | 53239195 |
| Antinuclear antibody | 21.35 | 15.97 | 8 | 21365 | 515 | 53327178 |
| Cholangitis | 21.32 | 15.97 | 17 | 21356 | 4996 | 53322697 |
| Autoimmune uveitis | 21.07 | 15.97 | 4 | 21369 | 15 | 53327678 |
| Meningitis aseptic | 21.01 | 15.97 | 16 | 21357 | 4399 | 53323294 |
| Adenocarcinoma | 21.00 | 15.97 | 13 | 21360 | 2556 | 53325137 |
| Silent thyroiditis | 20.74 | 15.97 | 5 | 21368 | 68 | 53327625 |
| Loss of consciousness | 20.58 | 15.97 | 10 | 21363 | 114202 | 53213491 |
| Rash morbilliform | 20.51 | 15.97 | 14 | 21359 | 3249 | 53324444 |
| Parathyroid tumour malignant | 20.48 | 15.97 | 4 | 21369 | 18 | 53327675 |
| Vesical fistula | 20.47 | 15.97 | 5 | 21368 | 72 | 53327621 |
| Depression | 20.43 | 15.97 | 26 | 21347 | 183026 | 53144667 |
| Pulmonary sarcoidosis | 20.28 | 15.97 | 9 | 21364 | 895 | 53326798 |
| Encephalitis | 19.95 | 15.97 | 20 | 21353 | 7924 | 53319769 |
| Weight increased | 19.92 | 15.97 | 32 | 21341 | 204535 | 53123158 |
| Palmar-plantar erythrodysaesthesia syndrome | 19.83 | 15.97 | 33 | 21340 | 21573 | 53306120 |
| Serous retinal detachment | 19.83 | 15.97 | 6 | 21367 | 199 | 53327494 |
| Alanine aminotransferase increased | 19.78 | 15.97 | 83 | 21290 | 95012 | 53232681 |
| Tumour pain | 19.55 | 15.97 | 10 | 21363 | 1364 | 53326329 |
| Contusion | 19.49 | 15.97 | 10 | 21363 | 110722 | 53216971 |
| Melanoma recurrent | 19.33 | 15.97 | 5 | 21368 | 92 | 53327601 |
| Stevens-Johnson syndrome | 19.25 | 15.97 | 35 | 21338 | 24547 | 53303146 |
| Neuropathy peripheral | 19.12 | 15.97 | 87 | 21286 | 103100 | 53224593 |
| No adverse event | 19.11 | 15.97 | 46 | 21327 | 39219 | 53288474 |
| EGFR gene mutation | 18.83 | 15.97 | 6 | 21367 | 237 | 53327456 |
| Blood pressure abnormal | 18.72 | 15.97 | 25 | 21348 | 13458 | 53314235 |
| Loss of personal independence in daily activities | 18.29 | 15.97 | 3 | 21370 | 69812 | 53257881 |
| Blood corticotrophin decreased | 18.20 | 15.97 | 6 | 21367 | 264 | 53327429 |
| Enterocolitis | 18.16 | 15.97 | 18 | 21355 | 7034 | 53320659 |
| Posterior reversible encephalopathy syndrome | 18.04 | 15.97 | 27 | 21346 | 16133 | 53311560 |
| Migraine | 17.92 | 15.97 | 5 | 21368 | 80412 | 53247281 |
| Sarcoidosis | 17.89 | 15.97 | 16 | 21357 | 5498 | 53322195 |
| Urogenital fistula | 17.80 | 15.97 | 5 | 21368 | 127 | 53327566 |
| Ototoxicity | 17.78 | 15.97 | 9 | 21364 | 1201 | 53326492 |
| Cholecystitis | 17.78 | 15.97 | 26 | 21347 | 15220 | 53312473 |
| Dermatitis bullous | 17.71 | 15.97 | 19 | 21354 | 8144 | 53319549 |
| Exposure via body fluid | 17.71 | 15.97 | 7 | 21366 | 521 | 53327172 |
| Peripheral swelling | 17.58 | 15.97 | 35 | 21338 | 206073 | 53121620 |
| Immune-mediated encephalopathy | 17.53 | 15.97 | 3 | 21370 | 5 | 53327688 |
| Insomnia | 17.53 | 15.97 | 30 | 21343 | 187042 | 53140651 |
| Achromotrichia acquired | 17.18 | 15.97 | 3 | 21370 | 6 | 53327687 |
| Diabetes mellitus | 17.11 | 15.97 | 54 | 21319 | 53845 | 53273848 |
| Pneumonia moraxella | 16.98 | 15.97 | 4 | 21369 | 49 | 53327644 |
| Nephropathy toxic | 16.94 | 15.97 | 19 | 21354 | 8553 | 53319140 |
| Cardiomyopathy | 16.90 | 15.97 | 27 | 21346 | 17061 | 53310632 |
| Infection | 16.70 | 15.97 | 27 | 21346 | 172178 | 53155515 |
| B-cell aplasia | 16.69 | 15.97 | 4 | 21369 | 53 | 53327640 |
| Vital functions abnormal | 16.63 | 15.97 | 6 | 21367 | 347 | 53327346 |
| Roseolovirus test positive | 16.62 | 15.97 | 4 | 21369 | 54 | 53327639 |
| Autoimmune thyroid disorder | 16.57 | 15.97 | 3 | 21370 | 8 | 53327685 |
| Musculoskeletal stiffness | 16.57 | 15.97 | 15 | 21358 | 123353 | 53204340 |
| Malignant melanoma | 16.50 | 15.97 | 21 | 21352 | 10781 | 53316912 |
| Radiation associated pain | 16.29 | 15.97 | 4 | 21369 | 59 | 53327634 |
| Muscle spasms | 16.26 | 15.97 | 18 | 21355 | 134777 | 53192916 |
| Influenza | 16.22 | 15.97 | 9 | 21364 | 95370 | 53232323 |
| Giant cell arteritis | 16.19 | 15.97 | 10 | 21363 | 1959 | 53325734 |
| 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 | 2251.50 | 14.14 | 1194 | 28659 | 77302 | 32406371 |
| Immune-mediated adverse reaction | 877.25 | 14.14 | 177 | 29676 | 325 | 32483348 |
| Product use in unapproved indication | 489.70 | 14.14 | 495 | 29358 | 86709 | 32396964 |
| Pneumonitis | 460.80 | 14.14 | 307 | 29546 | 29827 | 32453846 |
| Interstitial lung disease | 337.35 | 14.14 | 354 | 29499 | 64647 | 32419026 |
| Immune-mediated lung disease | 315.87 | 14.14 | 81 | 29772 | 582 | 32483091 |
| Immune-mediated hepatic disorder | 296.81 | 14.14 | 63 | 29790 | 165 | 32483508 |
| Immune-mediated enterocolitis | 294.29 | 14.14 | 94 | 29759 | 1581 | 32482092 |
| Immune-mediated myocarditis | 290.11 | 14.14 | 64 | 29789 | 213 | 32483460 |
| Immune-mediated hepatitis | 281.86 | 14.14 | 88 | 29765 | 1369 | 32482304 |
| Myasthenia gravis | 264.45 | 14.14 | 106 | 29747 | 3516 | 32480157 |
| Adverse event | 228.18 | 14.14 | 158 | 29695 | 16314 | 32467359 |
| Adrenal insufficiency | 227.54 | 14.14 | 140 | 29713 | 11828 | 32471845 |
| Tumour pseudoprogression | 224.81 | 14.14 | 57 | 29796 | 389 | 32483284 |
| Hypothyroidism | 207.80 | 14.14 | 151 | 29702 | 16824 | 32466849 |
| Colitis | 194.15 | 14.14 | 195 | 29658 | 33756 | 32449917 |
| Type 1 diabetes mellitus | 185.36 | 14.14 | 85 | 29768 | 3938 | 32479735 |
| Myocarditis | 169.54 | 14.14 | 115 | 29738 | 11475 | 32472198 |
| Product use issue | 166.37 | 14.14 | 223 | 29630 | 52554 | 32431119 |
| Off label use | 165.50 | 14.14 | 635 | 29218 | 305685 | 32177988 |
| Hypophysitis | 163.37 | 14.14 | 64 | 29789 | 1995 | 32481678 |
| Immune-mediated hypothyroidism | 159.32 | 14.14 | 31 | 29822 | 42 | 32483631 |
| Autoimmune hepatitis | 155.45 | 14.14 | 75 | 29778 | 3900 | 32479773 |
| Immune-mediated arthritis | 150.00 | 14.14 | 28 | 29825 | 25 | 32483648 |
| Therapy partial responder | 134.58 | 14.14 | 73 | 29780 | 4857 | 32478816 |
| Adrenocorticotropic hormone deficiency | 132.18 | 14.14 | 40 | 29813 | 557 | 32483116 |
| Myositis | 126.36 | 14.14 | 95 | 29758 | 11140 | 32472533 |
| Immune-mediated myositis | 122.18 | 14.14 | 49 | 29804 | 1626 | 32482047 |
| Autoimmune colitis | 120.18 | 14.14 | 42 | 29811 | 942 | 32482731 |
| Tubulointerstitial nephritis | 114.71 | 14.14 | 114 | 29739 | 19463 | 32464210 |
| Vitiligo | 114.18 | 14.14 | 38 | 29815 | 731 | 32482942 |
| Hyperthyroidism | 111.63 | 14.14 | 82 | 29771 | 9280 | 32474393 |
| Immune-mediated dermatitis | 103.25 | 14.14 | 20 | 29833 | 26 | 32483647 |
| Pemphigoid | 98.58 | 14.14 | 73 | 29780 | 8363 | 32475310 |
| Nephritis | 87.73 | 14.14 | 43 | 29810 | 2314 | 32481359 |
| Drug interaction | 87.05 | 14.14 | 46 | 29807 | 218139 | 32265534 |
| Inappropriate schedule of product administration | 86.80 | 14.14 | 153 | 29700 | 45672 | 32438001 |
| Immune-mediated pancreatitis | 84.29 | 14.14 | 17 | 29836 | 31 | 32483642 |
| Hepatitis | 83.74 | 14.14 | 106 | 29747 | 23587 | 32460086 |
| Thyroiditis | 79.36 | 14.14 | 38 | 29815 | 1942 | 32481731 |
| Completed suicide | 72.03 | 14.14 | 3 | 29850 | 92514 | 32391159 |
| Immune-mediated renal disorder | 71.70 | 14.14 | 13 | 29840 | 8 | 32483665 |
| Polymyalgia rheumatica | 71.11 | 14.14 | 31 | 29822 | 1272 | 32482401 |
| Death | 68.23 | 14.14 | 590 | 29263 | 381927 | 32101746 |
| Immune thrombocytopenia | 68.21 | 14.14 | 59 | 29794 | 8438 | 32475235 |
| Immune-mediated thyroiditis | 66.41 | 14.14 | 14 | 29839 | 35 | 32483638 |
| Tumour hyperprogression | 64.71 | 14.14 | 13 | 29840 | 23 | 32483650 |
| Diabetic ketoacidosis | 64.59 | 14.14 | 81 | 29772 | 17851 | 32465822 |
| Secondary adrenocortical insufficiency | 64.38 | 14.14 | 28 | 29825 | 1142 | 32482531 |
| Overdose | 61.19 | 14.14 | 5 | 29848 | 87072 | 32396601 |
| Fall | 60.16 | 14.14 | 55 | 29798 | 196146 | 32287527 |
| Neoplasm progression | 58.72 | 14.14 | 81 | 29772 | 19577 | 32464096 |
| Skin toxicity | 56.20 | 14.14 | 38 | 29815 | 3768 | 32479905 |
| Organising pneumonia | 55.07 | 14.14 | 44 | 29809 | 5637 | 32478036 |
| Hypopituitarism | 54.75 | 14.14 | 29 | 29824 | 1838 | 32481835 |
| Fulminant type 1 diabetes mellitus | 54.54 | 14.14 | 21 | 29832 | 624 | 32483049 |
| Metastatic malignant melanoma | 54.13 | 14.14 | 31 | 29822 | 2291 | 32481382 |
| Immune-mediated nephritis | 52.51 | 14.14 | 14 | 29839 | 119 | 32483554 |
| Eyelid ptosis | 51.76 | 14.14 | 42 | 29811 | 5500 | 32478173 |
| Cholangitis sclerosing | 50.85 | 14.14 | 23 | 29830 | 1031 | 32482642 |
| Hepatic function abnormal | 50.72 | 14.14 | 121 | 29732 | 44719 | 32438954 |
| Autoimmune hypothyroidism | 50.47 | 14.14 | 11 | 29842 | 34 | 32483639 |
| Autoimmune arthritis | 48.47 | 14.14 | 11 | 29842 | 43 | 32483630 |
| Autoimmune myocarditis | 47.79 | 14.14 | 14 | 29839 | 173 | 32483500 |
| Immune-mediated uveitis | 47.72 | 14.14 | 9 | 29844 | 9 | 32483664 |
| Autoimmune thyroiditis | 47.05 | 14.14 | 22 | 29831 | 1065 | 32482608 |
| Haemophagocytic lymphohistiocytosis | 45.35 | 14.14 | 54 | 29799 | 11281 | 32472392 |
| Pneumonia bacterial | 42.79 | 14.14 | 51 | 29802 | 10665 | 32473008 |
| Encephalitis autoimmune | 42.53 | 14.14 | 17 | 29836 | 559 | 32483114 |
| Subacute cutaneous lupus erythematosus | 40.74 | 14.14 | 18 | 29835 | 763 | 32482910 |
| Autoimmune pancreatitis | 40.61 | 14.14 | 14 | 29839 | 301 | 32483372 |
| Lichenoid keratosis | 40.42 | 14.14 | 26 | 29827 | 2370 | 32481303 |
| Myasthenic syndrome | 40.34 | 14.14 | 15 | 29838 | 404 | 32483269 |
| Immune-mediated encephalitis | 39.85 | 14.14 | 10 | 29843 | 65 | 32483608 |
| Hepatotoxicity | 39.77 | 14.14 | 67 | 29786 | 19270 | 32464403 |
| Lymphocytic hypophysitis | 39.46 | 14.14 | 12 | 29841 | 170 | 32483503 |
| Rash | 39.28 | 14.14 | 327 | 29526 | 209006 | 32274667 |
| Pericarditis malignant | 39.18 | 14.14 | 8 | 29845 | 16 | 32483657 |
| Immune-mediated hypophysitis | 39.18 | 14.14 | 8 | 29845 | 16 | 32483657 |
| Headache | 38.74 | 14.14 | 76 | 29777 | 196121 | 32287552 |
| Diarrhoea | 38.20 | 14.14 | 506 | 29347 | 364296 | 32119377 |
| Lung disorder | 38.07 | 14.14 | 91 | 29762 | 33663 | 32450010 |
| Colitis microscopic | 37.72 | 14.14 | 23 | 29830 | 1909 | 32481764 |
| Immune-mediated gastritis | 37.11 | 14.14 | 7 | 29846 | 7 | 32483666 |
| Plasma cell myeloma | 36.14 | 14.14 | 5 | 29848 | 57609 | 32426064 |
| Eosinophilic fasciitis | 35.70 | 14.14 | 10 | 29843 | 104 | 32483569 |
| Depression | 35.04 | 14.14 | 23 | 29830 | 97037 | 32386636 |
| Pulmonary toxicity | 35.00 | 14.14 | 32 | 29821 | 4921 | 32478752 |
| Hepatocellular injury | 34.98 | 14.14 | 74 | 29779 | 25244 | 32458429 |
| Autoimmune nephritis | 34.26 | 14.14 | 11 | 29842 | 188 | 32483485 |
| Dizziness | 34.23 | 14.14 | 90 | 29763 | 209528 | 32274145 |
| Toxic epidermal necrolysis | 34.21 | 14.14 | 65 | 29788 | 20528 | 32463145 |
| Immune-mediated cholangitis | 34.00 | 14.14 | 8 | 29845 | 38 | 32483635 |
| Immune-mediated endocrinopathy | 33.54 | 14.14 | 6 | 29847 | 3 | 32483670 |
| Toxicity to various agents | 33.41 | 14.14 | 71 | 29782 | 177970 | 32305703 |
| Myelosuppression | 33.21 | 14.14 | 47 | 29806 | 11629 | 32472044 |
| Pleural effusion | 33.10 | 14.14 | 152 | 29701 | 78840 | 32404833 |
| Metastases to central nervous system | 32.96 | 14.14 | 38 | 29815 | 7670 | 32476003 |
| Drug-induced liver injury | 32.86 | 14.14 | 70 | 29783 | 23993 | 32459680 |
| Primary biliary cholangitis | 32.54 | 14.14 | 10 | 29843 | 147 | 32483526 |
| Encephalitis | 32.28 | 14.14 | 36 | 29817 | 7008 | 32476665 |
| Immune-mediated cytopenia | 31.81 | 14.14 | 6 | 29847 | 6 | 32483667 |
| Hypothalamo-pituitary disorder | 31.74 | 14.14 | 15 | 29838 | 744 | 32482929 |
| Drug hypersensitivity | 31.44 | 14.14 | 14 | 29839 | 73386 | 32410287 |
| Mucosal inflammation | 31.30 | 14.14 | 84 | 29769 | 33350 | 32450323 |
| Thyroid disorder | 31.24 | 14.14 | 24 | 29829 | 2903 | 32480770 |
| Drug effective for unapproved indication | 30.34 | 14.14 | 18 | 29835 | 1421 | 32482252 |
| Melanoma recurrent | 29.50 | 14.14 | 9 | 29844 | 129 | 32483544 |
| Anxiety | 29.27 | 14.14 | 27 | 29826 | 95978 | 32387695 |
| Eastern Cooperative Oncology Group performance status worsened | 28.80 | 14.14 | 13 | 29840 | 580 | 32483093 |
| Radiation pneumonitis | 28.62 | 14.14 | 21 | 29832 | 2371 | 32481302 |
| Primary hypothyroidism | 28.24 | 14.14 | 7 | 29846 | 43 | 32483630 |
| Silent thyroiditis | 28.24 | 14.14 | 7 | 29846 | 43 | 32483630 |
| Optic neuritis | 28.07 | 14.14 | 24 | 29829 | 3378 | 32480295 |
| Agitation | 27.70 | 14.14 | 9 | 29844 | 57227 | 32426446 |
| Autoimmune uveitis | 27.62 | 14.14 | 5 | 29848 | 3 | 32483670 |
| Haemoglobin decreased | 27.56 | 14.14 | 42 | 29811 | 119629 | 32364044 |
| Decreased appetite | 27.39 | 14.14 | 246 | 29607 | 160567 | 32323106 |
| Hospitalisation | 26.91 | 14.14 | 6 | 29847 | 48965 | 32434708 |
| Enteritis | 26.46 | 14.14 | 33 | 29820 | 7228 | 32476445 |
| Stevens-Johnson syndrome | 26.21 | 14.14 | 55 | 29798 | 18654 | 32465019 |
| Paraneoplastic neurological syndrome | 25.95 | 14.14 | 6 | 29847 | 26 | 32483647 |
| Electrocardiogram QT prolonged | 25.93 | 14.14 | 3 | 29850 | 39638 | 32444035 |
| Bradycardia | 25.76 | 14.14 | 17 | 29836 | 71545 | 32412128 |
| Aggression | 25.72 | 14.14 | 3 | 29850 | 39386 | 32444287 |
| Insomnia | 25.31 | 14.14 | 33 | 29820 | 100315 | 32383358 |
| International normalised ratio increased | 25.02 | 14.14 | 7 | 29846 | 49028 | 32434645 |
| Pericardial effusion | 24.85 | 14.14 | 61 | 29792 | 22941 | 32460732 |
| Dermatitis | 24.70 | 14.14 | 35 | 29818 | 8669 | 32475004 |
| Transaminases increased | 23.54 | 14.14 | 63 | 29790 | 24965 | 32458708 |
| Lichen planus | 23.48 | 14.14 | 13 | 29840 | 900 | 32482773 |
| Latent autoimmune diabetes in adults | 23.40 | 14.14 | 6 | 29847 | 43 | 32483630 |
| Autoimmune disorder | 23.26 | 14.14 | 16 | 29837 | 1631 | 32482042 |
| Keratoacanthoma | 23.19 | 14.14 | 11 | 29842 | 550 | 32483123 |
| Blood thyroid stimulating hormone increased | 23.12 | 14.14 | 21 | 29832 | 3201 | 32480472 |
| Mixed liver injury | 22.93 | 14.14 | 19 | 29834 | 2561 | 32481112 |
| Autoimmune neuropathy | 22.83 | 14.14 | 6 | 29847 | 48 | 32483625 |
| Drug ineffective | 22.72 | 14.14 | 234 | 29619 | 383243 | 32100430 |
| Respiratory failure | 22.54 | 14.14 | 172 | 29681 | 107010 | 32376663 |
| Somnolence | 22.42 | 14.14 | 38 | 29815 | 103759 | 32379914 |
| Cardiac failure congestive | 22.34 | 14.14 | 27 | 29826 | 84825 | 32398848 |
| Hypertransaminasaemia | 22.05 | 14.14 | 23 | 29830 | 4151 | 32479522 |
| Hypotension | 21.93 | 14.14 | 113 | 29740 | 215997 | 32267676 |
| Cancer pain | 21.90 | 14.14 | 19 | 29834 | 2727 | 32480946 |
| Pain in extremity | 21.79 | 14.14 | 48 | 29805 | 118853 | 32364820 |
| Hypersensitivity | 21.78 | 14.14 | 13 | 29840 | 57745 | 32425928 |
| Adrenal disorder | 21.42 | 14.14 | 11 | 29842 | 654 | 32483019 |
| Blood pressure increased | 21.16 | 14.14 | 25 | 29828 | 79329 | 32404344 |
| Hallucination | 21.06 | 14.14 | 11 | 29842 | 52608 | 32431065 |
| Unevaluable event | 20.86 | 14.14 | 3 | 29850 | 33583 | 32450090 |
| Intentional product misuse | 20.66 | 14.14 | 4 | 29849 | 36047 | 32447626 |
| Injection site pain | 20.42 | 14.14 | 3 | 29850 | 33055 | 32450618 |
| Cardiac arrest | 20.38 | 14.14 | 36 | 29817 | 96740 | 32386933 |
| Blood thyroid stimulating hormone abnormal | 20.37 | 14.14 | 8 | 29845 | 251 | 32483422 |
| Paraneoplastic syndrome | 20.35 | 14.14 | 10 | 29843 | 541 | 32483132 |
| Guillain-Barre syndrome | 20.14 | 14.14 | 25 | 29828 | 5449 | 32478224 |
| Pulmonary sarcoidosis | 20.11 | 14.14 | 10 | 29843 | 555 | 32483118 |
| Loss of consciousness | 20.04 | 14.14 | 28 | 29825 | 82679 | 32400994 |
| Dermatomyositis | 20.02 | 14.14 | 13 | 29840 | 1204 | 32482469 |
| Cutaneous sarcoidosis | 19.98 | 14.14 | 7 | 29846 | 158 | 32483515 |
| Cholangitis | 19.96 | 14.14 | 31 | 29822 | 8327 | 32475346 |
| Rheumatoid nodule | 19.74 | 14.14 | 16 | 29837 | 2091 | 32481582 |
| Rash maculo-papular | 19.17 | 14.14 | 63 | 29790 | 27959 | 32455714 |
| Muscle spasms | 18.97 | 14.14 | 22 | 29831 | 70396 | 32413277 |
| Lymph node abscess | 18.44 | 14.14 | 4 | 29849 | 12 | 32483661 |
| Malignant pleural effusion | 18.33 | 14.14 | 13 | 29840 | 1392 | 32482281 |
| Limbic encephalitis | 18.08 | 14.14 | 8 | 29845 | 340 | 32483333 |
| Chest discomfort | 17.98 | 14.14 | 12 | 29841 | 50218 | 32433455 |
| Autoimmune cholangitis | 17.98 | 14.14 | 3 | 29850 | 0 | 32483673 |
| Non-small cell lung cancer stage III | 17.98 | 14.14 | 3 | 29850 | 0 | 32483673 |
| Overgrowth fungal | 17.98 | 14.14 | 3 | 29850 | 0 | 32483673 |
| Immune-mediated encephalopathy | 17.97 | 14.14 | 4 | 29849 | 14 | 32483659 |
| Transitional cell carcinoma recurrent | 17.97 | 14.14 | 4 | 29849 | 14 | 32483659 |
| Non-small cell lung cancer | 17.83 | 14.14 | 20 | 29833 | 3917 | 32479756 |
| Lymphangiosis carcinomatosa | 17.77 | 14.14 | 11 | 29842 | 938 | 32482735 |
| Autoimmune haemolytic anaemia | 17.76 | 14.14 | 21 | 29832 | 4353 | 32479320 |
| Syncope | 17.67 | 14.14 | 35 | 29818 | 90089 | 32393584 |
| Bacterial diarrhoea | 17.52 | 14.14 | 5 | 29848 | 56 | 32483617 |
| Pyrexia | 17.42 | 14.14 | 400 | 29453 | 319568 | 32164105 |
| Adrenalitis | 17.36 | 14.14 | 4 | 29849 | 17 | 32483656 |
| Tremor | 17.32 | 14.14 | 30 | 29823 | 81247 | 32402426 |
| Thyroid hormones increased | 17.28 | 14.14 | 5 | 29848 | 59 | 32483614 |
| Anti-thyroid antibody positive | 17.20 | 14.14 | 5 | 29848 | 60 | 32483613 |
| Metastases to skin | 17.15 | 14.14 | 8 | 29845 | 385 | 32483288 |
| Pancreatic failure | 16.99 | 14.14 | 10 | 29843 | 778 | 32482895 |
| Angina pectoris | 16.96 | 14.14 | 4 | 29849 | 31422 | 32452251 |
| Coma | 16.91 | 14.14 | 9 | 29844 | 42603 | 32441070 |
| Tumour ulceration | 16.91 | 14.14 | 5 | 29848 | 64 | 32483609 |
| Cardiac tamponade | 16.81 | 14.14 | 22 | 29831 | 5053 | 32478620 |
| Blood thyroid stimulating hormone decreased | 16.65 | 14.14 | 14 | 29839 | 1926 | 32481747 |
| Seizure | 16.61 | 14.14 | 45 | 29808 | 103809 | 32379864 |
| Blood bilirubin increased | 16.50 | 14.14 | 75 | 29778 | 38709 | 32444964 |
| Joint swelling | 16.42 | 14.14 | 14 | 29839 | 51721 | 32431952 |
| Dyspepsia | 16.34 | 14.14 | 5 | 29848 | 33050 | 32450623 |
| Myocardial infarction | 16.20 | 14.14 | 60 | 29793 | 125616 | 32358057 |
| Blood corticotrophin decreased | 16.19 | 14.14 | 6 | 29847 | 160 | 32483513 |
| Abdominal distension | 16.13 | 14.14 | 14 | 29839 | 51281 | 32432392 |
| Nasopharyngitis | 16.05 | 14.14 | 21 | 29832 | 63766 | 32419907 |
| Hepatitis E virus test positive | 15.81 | 14.14 | 4 | 29849 | 27 | 32483646 |
| Treatment noncompliance | 15.63 | 14.14 | 3 | 29850 | 27199 | 32456474 |
| Autoimmune myositis | 15.60 | 14.14 | 5 | 29848 | 85 | 32483588 |
| Hepatic enzyme increased | 15.30 | 14.14 | 71 | 29782 | 36966 | 32446707 |
| Radiation necrosis | 15.28 | 14.14 | 5 | 29848 | 91 | 32483582 |
| Large intestine perforation | 15.18 | 14.14 | 27 | 29826 | 8103 | 32475570 |
| Coronary artery disease | 15.11 | 14.14 | 14 | 29839 | 49692 | 32433981 |
| Cachexia | 15.11 | 14.14 | 25 | 29828 | 7084 | 32476589 |
| Meningitis aseptic | 14.97 | 14.14 | 15 | 29838 | 2582 | 32481091 |
| Condition aggravated | 14.88 | 14.14 | 83 | 29770 | 155578 | 32328095 |
| Stoma site dermatitis | 14.69 | 14.14 | 3 | 29850 | 6 | 32483667 |
| Immunisation reaction | 14.69 | 14.14 | 3 | 29850 | 6 | 32483667 |
| Tumour rupture | 14.50 | 14.14 | 6 | 29847 | 216 | 32483457 |
| Haematoma | 14.40 | 14.14 | 3 | 29850 | 25681 | 32457992 |
| Tumour pain | 14.30 | 14.14 | 10 | 29843 | 1047 | 32482626 |
| Tumour haemorrhage | 14.25 | 14.14 | 15 | 29838 | 2736 | 32480937 |
| Dysphagia | 14.25 | 14.14 | 101 | 29752 | 61375 | 32422298 |
| 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 |
| 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
| 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 | 0006-3029 | 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 |