Stem definition | Drug id | CAS RN |
---|---|---|
5133 | 1257044-40-8 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 5, 2016 | EMA | AbbVie Ltd | |
April 11, 2016 | FDA | ABBVIE INC | |
Sept. 20, 2019 | PMDA | AbbVie GK |
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 |
---|---|---|---|---|---|---|
Death | 1330.25 | 22.42 | 926 | 14198 | 340500 | 55936443 |
Febrile neutropenia | 853.50 | 22.42 | 459 | 14665 | 105086 | 56171857 |
Acute myeloid leukaemia | 693.81 | 22.42 | 234 | 14890 | 16738 | 56260205 |
Off label use | 583.90 | 22.42 | 727 | 14397 | 555453 | 55721490 |
Neutropenia | 525.55 | 22.42 | 392 | 14732 | 157775 | 56119168 |
Tumour lysis syndrome | 503.95 | 22.42 | 153 | 14971 | 7770 | 56269173 |
Chronic lymphocytic leukaemia | 467.13 | 22.42 | 117 | 15007 | 2871 | 56274072 |
Hospice care | 311.79 | 22.42 | 100 | 15024 | 6080 | 56270863 |
Intentional product use issue | 256.51 | 22.42 | 213 | 14911 | 99520 | 56177423 |
Thrombocytopenia | 226.90 | 22.42 | 228 | 14896 | 135996 | 56140947 |
Sepsis | 218.27 | 22.42 | 226 | 14898 | 139614 | 56137329 |
Acute myeloid leukaemia recurrent | 205.11 | 22.42 | 53 | 15071 | 1475 | 56275468 |
Pancytopenia | 198.48 | 22.42 | 175 | 14949 | 88540 | 56188403 |
Cytopenia | 182.71 | 22.42 | 76 | 15048 | 9679 | 56267264 |
COVID-19 | 167.71 | 22.42 | 148 | 14976 | 74910 | 56202033 |
Neutrophil count decreased | 165.83 | 22.42 | 124 | 15000 | 49698 | 56227245 |
Myelosuppression | 160.39 | 22.42 | 83 | 15041 | 17372 | 56259571 |
Platelet count decreased | 146.47 | 22.42 | 161 | 14963 | 106222 | 56170721 |
Pneumonia | 139.87 | 22.42 | 325 | 14799 | 406773 | 55870170 |
Disease progression | 120.84 | 22.42 | 145 | 14979 | 105028 | 56171915 |
White blood cell count decreased | 88.74 | 22.42 | 137 | 14987 | 125853 | 56151090 |
Lymphadenopathy | 85.77 | 22.42 | 73 | 15051 | 35135 | 56241808 |
Pyrexia | 81.47 | 22.42 | 272 | 14852 | 418501 | 55858442 |
Pain | 80.57 | 22.42 | 39 | 15085 | 663145 | 55613798 |
Infection | 77.56 | 22.42 | 168 | 14956 | 200038 | 56076905 |
Allogenic stem cell transplantation | 71.37 | 22.42 | 12 | 15112 | 31 | 56276912 |
Bone marrow transplant | 69.41 | 22.42 | 19 | 15105 | 662 | 56276281 |
Joint swelling | 65.28 | 22.42 | 3 | 15121 | 289797 | 55987146 |
Acute myeloid leukaemia refractory | 64.38 | 22.42 | 12 | 15112 | 65 | 56276878 |
Hyperuricaemia | 64.14 | 22.42 | 30 | 15094 | 5043 | 56271900 |
Anaemia | 62.21 | 22.42 | 185 | 14939 | 267326 | 56009617 |
Septic shock | 61.94 | 22.42 | 79 | 15045 | 60756 | 56216187 |
Mantle cell lymphoma | 61.92 | 22.42 | 17 | 15107 | 599 | 56276344 |
Blood lactate dehydrogenase increased | 58.98 | 22.42 | 47 | 15077 | 20628 | 56256315 |
Blast cell count increased | 58.61 | 22.42 | 15 | 15109 | 401 | 56276542 |
Rhinovirus infection | 55.24 | 22.42 | 25 | 15099 | 3897 | 56273046 |
Chronic lymphocytic leukaemia transformation | 55.19 | 22.42 | 10 | 15114 | 45 | 56276898 |
Pneumonia fungal | 52.93 | 22.42 | 26 | 15098 | 4867 | 56272076 |
Arthralgia | 52.92 | 22.42 | 35 | 15089 | 501634 | 55775309 |
Drug ineffective | 50.25 | 22.42 | 108 | 15016 | 918881 | 55358062 |
Headache | 47.79 | 22.42 | 48 | 15076 | 558996 | 55717947 |
Swelling | 46.76 | 22.42 | 5 | 15119 | 239766 | 56037177 |
Myelodysplastic syndrome | 46.16 | 22.42 | 37 | 15087 | 16369 | 56260574 |
Hyperphosphataemia | 45.45 | 22.42 | 18 | 15106 | 2017 | 56274926 |
Aspergillus infection | 45.22 | 22.42 | 27 | 15097 | 7438 | 56269505 |
T-cell prolymphocytic leukaemia | 43.95 | 22.42 | 7 | 15117 | 11 | 56276932 |
Rash | 43.66 | 22.42 | 41 | 15083 | 493006 | 55783937 |
Chronic lymphocytic leukaemia refractory | 42.97 | 22.42 | 8 | 15116 | 43 | 56276900 |
Hospitalisation | 42.51 | 22.42 | 74 | 15050 | 74926 | 56202017 |
COVID-19 pneumonia | 42.26 | 22.42 | 30 | 15094 | 11072 | 56265871 |
Diffuse large B-cell lymphoma | 41.53 | 22.42 | 25 | 15099 | 6991 | 56269952 |
Minimal residual disease | 41.43 | 22.42 | 9 | 15115 | 115 | 56276828 |
Bone marrow failure | 40.91 | 22.42 | 44 | 15080 | 28242 | 56248701 |
Transformation to acute myeloid leukaemia | 40.26 | 22.42 | 10 | 15114 | 236 | 56276707 |
Escherichia sepsis | 40.13 | 22.42 | 21 | 15103 | 4488 | 56272455 |
Atrial fibrillation | 39.39 | 22.42 | 89 | 15035 | 108808 | 56168135 |
Product dose omission issue | 38.10 | 22.42 | 5 | 15119 | 204748 | 56072195 |
Pneumonia adenoviral | 35.82 | 22.42 | 8 | 15116 | 117 | 56276826 |
Bronchopulmonary aspergillosis | 35.37 | 22.42 | 24 | 15100 | 8240 | 56268703 |
Non-small cell lung cancer | 35.33 | 22.42 | 18 | 15106 | 3640 | 56273303 |
Drug hypersensitivity | 35.13 | 22.42 | 15 | 15109 | 275190 | 56001753 |
Periorbital cellulitis | 34.80 | 22.42 | 11 | 15113 | 636 | 56276307 |
Leukaemia | 34.80 | 22.42 | 18 | 15106 | 3757 | 56273186 |
Maternal exposure during pregnancy | 34.39 | 22.42 | 5 | 15119 | 189548 | 56087395 |
Escherichia bacteraemia | 33.34 | 22.42 | 17 | 15107 | 3443 | 56273500 |
Pleural effusion | 33.32 | 22.42 | 72 | 15052 | 85408 | 56191535 |
Abdominal discomfort | 32.49 | 22.42 | 17 | 15107 | 277257 | 55999686 |
Synovitis | 32.38 | 22.42 | 3 | 15121 | 161302 | 56115641 |
Soft tissue infection | 32.27 | 22.42 | 14 | 15110 | 1973 | 56274970 |
Nasopharyngitis | 31.64 | 22.42 | 10 | 15114 | 220949 | 56055994 |
Blood phosphorus increased | 30.77 | 22.42 | 15 | 15109 | 2761 | 56274182 |
Infusion related reaction | 30.73 | 22.42 | 9 | 15115 | 208922 | 56068021 |
Febrile bone marrow aplasia | 30.32 | 22.42 | 20 | 15104 | 6552 | 56270391 |
Bacteraemia | 29.34 | 22.42 | 28 | 15096 | 15603 | 56261340 |
Plasma cell myeloma | 29.03 | 22.42 | 48 | 15076 | 46598 | 56230345 |
Splenomegaly | 28.75 | 22.42 | 23 | 15101 | 10145 | 56266798 |
Respiratory failure | 28.23 | 22.42 | 72 | 15052 | 94990 | 56181953 |
Neutropenic sepsis | 28.12 | 22.42 | 27 | 15097 | 15158 | 56261785 |
Peripheral swelling | 28.07 | 22.42 | 14 | 15110 | 234712 | 56042231 |
Dizziness | 28.04 | 22.42 | 36 | 15088 | 376104 | 55900839 |
Hepatic enzyme increased | 27.87 | 22.42 | 6 | 15118 | 171378 | 56105565 |
Adenoviral hepatitis | 27.62 | 22.42 | 8 | 15116 | 343 | 56276600 |
Blood uric acid increased | 27.42 | 22.42 | 16 | 15108 | 4226 | 56272717 |
Stem cell transplant | 27.39 | 22.42 | 12 | 15112 | 1732 | 56275211 |
Autoimmune haemolytic anaemia | 27.30 | 22.42 | 16 | 15108 | 4260 | 56272683 |
Leukaemia recurrent | 27.07 | 22.42 | 11 | 15113 | 1317 | 56275626 |
Exposure during pregnancy | 26.16 | 22.42 | 3 | 15121 | 136339 | 56140604 |
Pseudomonal skin infection | 26.12 | 22.42 | 4 | 15120 | 4 | 56276939 |
Transplant | 26.08 | 22.42 | 9 | 15115 | 685 | 56276258 |
Blood pressure increased | 25.94 | 22.42 | 4 | 15120 | 145172 | 56131771 |
Splenic abscess | 25.49 | 22.42 | 6 | 15118 | 112 | 56276831 |
Hypophosphataemia | 25.43 | 22.42 | 21 | 15103 | 9681 | 56267262 |
Portal vein cavernous transformation | 25.20 | 22.42 | 6 | 15118 | 118 | 56276825 |
Hypoaesthesia | 25.05 | 22.42 | 4 | 15120 | 141487 | 56135456 |
Pruritus | 24.96 | 22.42 | 29 | 15095 | 316594 | 55960349 |
Multiple organ dysfunction syndrome | 24.75 | 22.42 | 48 | 15076 | 52722 | 56224221 |
Fungal sepsis | 24.74 | 22.42 | 10 | 15114 | 1181 | 56275762 |
Cerebral haemorrhage | 24.27 | 22.42 | 34 | 15090 | 28572 | 56248371 |
Nonspecific reaction | 23.39 | 22.42 | 11 | 15113 | 1870 | 56275073 |
Lymphocyte count decreased | 23.39 | 22.42 | 33 | 15091 | 27906 | 56249037 |
Subdural haematoma | 23.12 | 22.42 | 23 | 15101 | 13476 | 56263467 |
Terminal ileitis | 23.06 | 22.42 | 8 | 15116 | 619 | 56276324 |
Discomfort | 22.97 | 22.42 | 5 | 15119 | 141756 | 56135187 |
Pain in extremity | 22.64 | 22.42 | 28 | 15096 | 297403 | 55979540 |
Campylobacter gastroenteritis | 22.54 | 22.42 | 7 | 15117 | 382 | 56276561 |
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 |
---|---|---|---|---|---|---|
Death | 1535.95 | 18.84 | 1675 | 24820 | 358894 | 31311955 |
Acute myeloid leukaemia | 912.64 | 18.84 | 399 | 26096 | 18273 | 31652576 |
Febrile neutropenia | 895.95 | 18.84 | 769 | 25726 | 121080 | 31549769 |
Off label use | 877.17 | 18.84 | 1246 | 25249 | 346028 | 31324821 |
Tumour lysis syndrome | 801.50 | 18.84 | 344 | 26151 | 15041 | 31655808 |
Chronic lymphocytic leukaemia | 665.12 | 18.84 | 220 | 26275 | 4596 | 31666253 |
Neutropenia | 585.55 | 18.84 | 650 | 25845 | 139714 | 31531135 |
Hospice care | 453.82 | 18.84 | 172 | 26323 | 5404 | 31665445 |
Intentional product use issue | 396.97 | 18.84 | 329 | 26166 | 49018 | 31621831 |
COVID-19 | 347.23 | 18.84 | 319 | 26176 | 54502 | 31616347 |
Cytopenia | 239.77 | 18.84 | 136 | 26359 | 10874 | 31659975 |
Pneumonia | 202.44 | 18.84 | 676 | 25819 | 334636 | 31336213 |
Thrombocytopenia | 180.79 | 18.84 | 380 | 26115 | 142367 | 31528482 |
Sepsis | 169.15 | 18.84 | 384 | 26111 | 151545 | 31519304 |
Disease progression | 166.93 | 18.84 | 283 | 26212 | 90181 | 31580668 |
Pancytopenia | 164.89 | 18.84 | 276 | 26219 | 87040 | 31583809 |
Neutrophil count decreased | 157.57 | 18.84 | 194 | 26301 | 46200 | 31624649 |
Myelosuppression | 150.92 | 18.84 | 114 | 26381 | 14806 | 31656043 |
Infection | 149.38 | 18.84 | 255 | 26240 | 81676 | 31589173 |
Acute myeloid leukaemia recurrent | 143.08 | 18.84 | 56 | 26439 | 1918 | 31668931 |
Lymphadenopathy | 142.24 | 18.84 | 140 | 26355 | 25981 | 31644868 |
Mantle cell lymphoma | 127.49 | 18.84 | 50 | 26445 | 1722 | 31669127 |
Platelet count decreased | 117.04 | 18.84 | 274 | 26221 | 110161 | 31560688 |
COVID-19 pneumonia | 96.61 | 18.84 | 82 | 26413 | 12573 | 31658276 |
Hyperphosphataemia | 96.14 | 18.84 | 45 | 26450 | 2404 | 31668445 |
Chronic lymphocytic leukaemia recurrent | 86.60 | 18.84 | 26 | 26469 | 389 | 31670460 |
White blood cell count decreased | 85.15 | 18.84 | 210 | 26285 | 87188 | 31583661 |
Transplant | 84.83 | 18.84 | 30 | 26465 | 769 | 31670080 |
Autoimmune haemolytic anaemia | 84.02 | 18.84 | 49 | 26446 | 4123 | 31666726 |
Pneumonia fungal | 83.84 | 18.84 | 57 | 26438 | 6272 | 31664577 |
Pyrexia | 82.44 | 18.84 | 483 | 26012 | 303357 | 31367492 |
Toxicity to various agents | 81.93 | 18.84 | 25 | 26470 | 181462 | 31489387 |
Lymphocyte count increased | 74.42 | 18.84 | 40 | 26455 | 2873 | 31667976 |
Splenomegaly | 69.85 | 18.84 | 71 | 26424 | 13678 | 31657171 |
Bacteraemia | 68.45 | 18.84 | 79 | 26416 | 17555 | 31653294 |
Septic shock | 64.43 | 18.84 | 159 | 26336 | 65999 | 31604850 |
Completed suicide | 63.88 | 18.84 | 3 | 26492 | 91511 | 31579338 |
Product dose omission issue | 58.83 | 18.84 | 9 | 26486 | 105577 | 31565272 |
Blast cell count increased | 56.81 | 18.84 | 24 | 26471 | 1003 | 31669846 |
Hyperuricaemia | 56.36 | 18.84 | 48 | 26447 | 7390 | 31663459 |
Myelodysplastic syndrome | 55.06 | 18.84 | 74 | 26421 | 19177 | 31651672 |
Anaemia | 53.62 | 18.84 | 333 | 26162 | 213189 | 31457660 |
Hospitalisation | 52.00 | 18.84 | 123 | 26372 | 49684 | 31621165 |
Blood pressure increased | 48.69 | 18.84 | 5 | 26490 | 79628 | 31591221 |
Drug interaction | 48.46 | 18.84 | 62 | 26433 | 208481 | 31462368 |
Neutropenic sepsis | 47.27 | 18.84 | 55 | 26440 | 12324 | 31658525 |
Soft tissue infection | 47.27 | 18.84 | 26 | 26469 | 1955 | 31668894 |
Stem cell transplant | 46.46 | 18.84 | 26 | 26469 | 2022 | 31668827 |
Leukaemia | 45.73 | 18.84 | 33 | 26462 | 3992 | 31666857 |
Headache | 44.34 | 18.84 | 53 | 26442 | 183599 | 31487250 |
Hypocalcaemia | 43.41 | 18.84 | 71 | 26424 | 21907 | 31648942 |
Condition aggravated | 43.25 | 18.84 | 44 | 26451 | 163965 | 31506884 |
Mantle cell lymphoma refractory | 42.87 | 18.84 | 11 | 26484 | 88 | 31670761 |
Lymphocytosis | 42.85 | 18.84 | 25 | 26470 | 2104 | 31668745 |
Blast cell count decreased | 42.62 | 18.84 | 7 | 26488 | 0 | 31670849 |
Blood phosphorus increased | 42.56 | 18.84 | 33 | 26462 | 4449 | 31666400 |
Skin infection | 41.51 | 18.84 | 39 | 26456 | 6824 | 31664025 |
Overdose | 41.27 | 18.84 | 10 | 26485 | 84654 | 31586195 |
Acute myeloid leukaemia refractory | 40.14 | 18.84 | 9 | 26486 | 37 | 31670812 |
Weight increased | 40.04 | 18.84 | 10 | 26485 | 82937 | 31587912 |
Minimal residual disease | 39.91 | 18.84 | 14 | 26481 | 350 | 31670499 |
Pain | 38.91 | 18.84 | 60 | 26435 | 186699 | 31484150 |
Depression | 38.32 | 18.84 | 14 | 26481 | 90801 | 31580048 |
Somnolence | 37.67 | 18.84 | 18 | 26477 | 99427 | 31571422 |
Chemotherapy | 37.20 | 18.84 | 15 | 26480 | 556 | 31670293 |
Pain in extremity | 36.96 | 18.84 | 26 | 26469 | 116177 | 31554672 |
Tremor | 35.39 | 18.84 | 10 | 26485 | 76410 | 31594439 |
Bone marrow transplant | 35.09 | 18.84 | 17 | 26478 | 981 | 31669868 |
Squamous cell carcinoma | 35.03 | 18.84 | 44 | 26451 | 10667 | 31660182 |
Pruritus | 34.82 | 18.84 | 32 | 26463 | 125135 | 31545714 |
Lymphocyte count decreased | 34.58 | 18.84 | 62 | 26433 | 20587 | 31650262 |
Bronchopulmonary aspergillosis | 33.89 | 18.84 | 49 | 26446 | 13585 | 31657264 |
Blood uric acid abnormal | 33.84 | 18.84 | 9 | 26486 | 84 | 31670765 |
Hypogammaglobulinaemia | 33.25 | 18.84 | 34 | 26461 | 6593 | 31664256 |
Allogenic stem cell transplantation | 32.90 | 18.84 | 8 | 26487 | 50 | 31670799 |
Escherichia bacteraemia | 32.72 | 18.84 | 24 | 26471 | 2977 | 31667872 |
Anxiety | 32.21 | 18.84 | 18 | 26477 | 91015 | 31579834 |
Blood lactate dehydrogenase increased | 31.45 | 18.84 | 59 | 26436 | 20280 | 31650569 |
Chronic lymphocytic leukaemia transformation | 31.43 | 18.84 | 10 | 26485 | 183 | 31670666 |
Rash | 31.31 | 18.84 | 77 | 26418 | 201409 | 31469440 |
Haemolysis | 30.84 | 18.84 | 34 | 26461 | 7182 | 31663667 |
Sinusitis fungal | 30.66 | 18.84 | 13 | 26482 | 548 | 31670301 |
Haemoglobin abnormal | 29.96 | 18.84 | 24 | 26471 | 3391 | 31667458 |
Dizziness | 29.48 | 18.84 | 78 | 26417 | 199069 | 31471780 |
Blood uric acid increased | 28.95 | 18.84 | 31 | 26464 | 6339 | 31664510 |
Full blood count abnormal | 28.55 | 18.84 | 50 | 26445 | 16297 | 31654552 |
B-cell small lymphocytic lymphoma | 28.22 | 18.84 | 9 | 26486 | 166 | 31670683 |
T-cell prolymphocytic leukaemia | 28.10 | 18.84 | 7 | 26488 | 49 | 31670800 |
Blastic plasmacytoid dendritic cell neoplasia | 27.89 | 18.84 | 8 | 26487 | 101 | 31670748 |
Haematotoxicity | 27.73 | 18.84 | 32 | 26463 | 7105 | 31663744 |
Arthralgia | 27.54 | 18.84 | 53 | 26442 | 151371 | 31519478 |
Chronic lymphocytic leukaemia refractory | 27.40 | 18.84 | 8 | 26487 | 108 | 31670741 |
Agitation | 27.18 | 18.84 | 6 | 26489 | 54163 | 31616686 |
Seizure | 27.15 | 18.84 | 26 | 26469 | 99742 | 31571107 |
Gait disturbance | 26.45 | 18.84 | 16 | 26479 | 77479 | 31593370 |
White blood cell count abnormal | 26.10 | 18.84 | 21 | 26474 | 2986 | 31667863 |
Transfusion | 25.97 | 18.84 | 32 | 26463 | 7608 | 31663241 |
Chest pain | 25.87 | 18.84 | 36 | 26459 | 116921 | 31553928 |
Hallucination | 25.73 | 18.84 | 4 | 26491 | 46406 | 31624443 |
Atrial fibrillation | 25.73 | 18.84 | 173 | 26322 | 113610 | 31557239 |
International normalised ratio increased | 24.84 | 18.84 | 4 | 26491 | 45219 | 31625630 |
Mantle cell lymphoma recurrent | 24.84 | 18.84 | 11 | 26484 | 516 | 31670333 |
Joint swelling | 24.72 | 18.84 | 7 | 26488 | 53424 | 31617425 |
Coronavirus infection | 24.35 | 18.84 | 22 | 26473 | 3661 | 31667188 |
Bradycardia | 24.10 | 18.84 | 14 | 26481 | 69313 | 31601536 |
Confusional state | 23.95 | 18.84 | 47 | 26448 | 133287 | 31537562 |
Cellulitis | 23.68 | 18.84 | 91 | 26404 | 47927 | 31622922 |
Klebsiella sepsis | 22.90 | 18.84 | 16 | 26479 | 1839 | 31669010 |
Influenza | 22.68 | 18.84 | 85 | 26410 | 44240 | 31626609 |
Drug ineffective | 22.50 | 18.84 | 217 | 26278 | 395356 | 31275493 |
General physical health deterioration | 21.88 | 18.84 | 166 | 26329 | 113269 | 31557580 |
Rhabdomyolysis | 21.87 | 18.84 | 13 | 26482 | 63568 | 31607281 |
Blood product transfusion dependent | 21.53 | 18.84 | 9 | 26486 | 366 | 31670483 |
Diffuse large B-cell lymphoma | 21.39 | 18.84 | 31 | 26464 | 8610 | 31662239 |
Plasma cell leukaemia | 21.37 | 18.84 | 12 | 26483 | 939 | 31669910 |
Angiodysplasia | 21.28 | 18.84 | 10 | 26485 | 539 | 31670310 |
Blood pressure decreased | 20.98 | 18.84 | 7 | 26488 | 48084 | 31622765 |
Urticaria | 20.88 | 18.84 | 11 | 26484 | 57506 | 31613343 |
Diabetes mellitus | 20.78 | 18.84 | 5 | 26490 | 42551 | 31628298 |
Platelet count abnormal | 20.38 | 18.84 | 17 | 26478 | 2542 | 31668307 |
Blood creatine phosphokinase increased | 20.36 | 18.84 | 5 | 26490 | 41969 | 31628880 |
Fungal sepsis | 20.16 | 18.84 | 11 | 26484 | 814 | 31670035 |
Epstein-Barr virus infection reactivation | 20.00 | 18.84 | 11 | 26484 | 827 | 31670022 |
Hypersensitivity | 19.74 | 18.84 | 11 | 26484 | 55732 | 31615117 |
Transfusion reaction | 19.59 | 18.84 | 11 | 26484 | 861 | 31669988 |
Insomnia | 19.21 | 18.84 | 31 | 26464 | 94805 | 31576044 |
Palliative care | 19.17 | 18.84 | 9 | 26486 | 484 | 31670365 |
Respiratory tract infection | 19.00 | 18.84 | 44 | 26451 | 17517 | 31653332 |
Nasopharyngitis | 19.00 | 18.84 | 15 | 26480 | 63230 | 31607619 |
Pneumocystis jirovecii pneumonia | 18.95 | 18.84 | 45 | 26450 | 18206 | 31652643 |
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 |
---|---|---|---|---|---|---|
Febrile neutropenia | 1813.39 | 18.84 | 1163 | 33348 | 203155 | 70690778 |
Death | 1553.29 | 18.84 | 1545 | 32966 | 508516 | 70385417 |
Acute myeloid leukaemia | 1231.39 | 18.84 | 489 | 34022 | 30451 | 70863482 |
Tumour lysis syndrome | 1157.61 | 18.84 | 423 | 34088 | 20937 | 70872996 |
Neutropenia | 1005.72 | 18.84 | 898 | 33613 | 256258 | 70637675 |
Chronic lymphocytic leukaemia | 834.54 | 18.84 | 241 | 34270 | 5557 | 70888376 |
Off label use | 656.19 | 18.84 | 1236 | 33275 | 741824 | 70152109 |
Pneumonia | 422.59 | 18.84 | 907 | 33604 | 595325 | 70298608 |
Sepsis | 419.89 | 18.84 | 554 | 33957 | 243991 | 70649942 |
Thrombocytopenia | 412.53 | 18.84 | 543 | 33968 | 238567 | 70655366 |
Cytopenia | 358.57 | 18.84 | 173 | 34338 | 17150 | 70876783 |
COVID-19 | 345.21 | 18.84 | 335 | 34176 | 105422 | 70788511 |
Neutrophil count decreased | 339.23 | 18.84 | 299 | 34212 | 83257 | 70810676 |
Myelosuppression | 299.01 | 18.84 | 185 | 34326 | 29960 | 70863973 |
Acute myeloid leukaemia recurrent | 272.75 | 18.84 | 88 | 34423 | 2966 | 70890967 |
Pancytopenia | 269.19 | 18.84 | 349 | 34162 | 150758 | 70743175 |
Platelet count decreased | 248.89 | 18.84 | 366 | 34145 | 177856 | 70716077 |
Intentional product use issue | 208.42 | 18.84 | 274 | 34237 | 119868 | 70774065 |
Disease progression | 190.73 | 18.84 | 302 | 34209 | 156370 | 70737563 |
Lymphadenopathy | 186.75 | 18.84 | 169 | 34342 | 48622 | 70845311 |
Pyrexia | 185.48 | 18.84 | 681 | 33830 | 606271 | 70287662 |
Infection | 184.31 | 18.84 | 351 | 34160 | 210434 | 70683499 |
Hospice care | 182.11 | 18.84 | 86 | 34425 | 8119 | 70885814 |
White blood cell count decreased | 167.15 | 18.84 | 298 | 34213 | 169843 | 70724090 |
Mantle cell lymphoma | 146.83 | 18.84 | 48 | 34463 | 1687 | 70892246 |
Septic shock | 138.74 | 18.84 | 218 | 34293 | 112040 | 70781893 |
Anaemia | 136.88 | 18.84 | 469 | 34042 | 402954 | 70490979 |
Hyperphosphataemia | 133.82 | 18.84 | 57 | 34454 | 4219 | 70889714 |
COVID-19 pneumonia | 132.17 | 18.84 | 99 | 34412 | 21870 | 70872063 |
Pain | 130.59 | 18.84 | 72 | 34439 | 628744 | 70265189 |
Pneumonia fungal | 127.25 | 18.84 | 72 | 34439 | 9881 | 70884052 |
Bacteraemia | 123.03 | 18.84 | 107 | 34404 | 29202 | 70864731 |
Hyperuricaemia | 120.76 | 18.84 | 72 | 34439 | 10894 | 70883039 |
Blast cell count increased | 109.15 | 18.84 | 36 | 34475 | 1301 | 70892632 |
Joint swelling | 96.32 | 18.84 | 7 | 34504 | 253204 | 70640729 |
Headache | 92.35 | 18.84 | 88 | 34423 | 580317 | 70313616 |
Toxicity to various agents | 91.17 | 18.84 | 36 | 34475 | 382136 | 70511797 |
Chronic lymphocytic leukaemia recurrent | 90.39 | 18.84 | 26 | 34485 | 589 | 70893344 |
Splenomegaly | 89.67 | 18.84 | 74 | 34437 | 18796 | 70875137 |
Myelodysplastic syndrome | 88.93 | 18.84 | 90 | 34421 | 29695 | 70864238 |
Blood lactate dehydrogenase increased | 86.86 | 18.84 | 96 | 34415 | 35031 | 70858902 |
Arthralgia | 86.45 | 18.84 | 71 | 34440 | 503319 | 70390614 |
Autoimmune haemolytic anaemia | 85.66 | 18.84 | 51 | 34460 | 7695 | 70886238 |
Allogenic stem cell transplantation | 84.94 | 18.84 | 16 | 34495 | 44 | 70893889 |
Soft tissue infection | 84.24 | 18.84 | 39 | 34472 | 3518 | 70890415 |
Atrial fibrillation | 78.46 | 18.84 | 232 | 34279 | 184116 | 70709817 |
Bronchopulmonary aspergillosis | 76.90 | 18.84 | 71 | 34440 | 20931 | 70873002 |
Rash | 71.58 | 18.84 | 86 | 34425 | 510476 | 70383457 |
Neutropenic sepsis | 70.45 | 18.84 | 73 | 34438 | 24757 | 70869176 |
Lymphocytosis | 69.02 | 18.84 | 35 | 34476 | 3855 | 70890078 |
Pruritus | 68.11 | 18.84 | 42 | 34469 | 345518 | 70548415 |
Product dose omission issue | 67.82 | 18.84 | 12 | 34499 | 217456 | 70676477 |
Blood pressure increased | 66.82 | 18.84 | 7 | 34504 | 188510 | 70705423 |
Escherichia bacteraemia | 65.83 | 18.84 | 39 | 34472 | 5830 | 70888103 |
Swelling | 64.32 | 18.84 | 8 | 34503 | 188531 | 70705402 |
Rhinovirus infection | 63.39 | 18.84 | 40 | 34471 | 6693 | 70887240 |
Blood phosphorus increased | 63.18 | 18.84 | 40 | 34471 | 6730 | 70887203 |
Escherichia sepsis | 61.64 | 18.84 | 41 | 34470 | 7502 | 70886431 |
Pain in extremity | 60.43 | 18.84 | 43 | 34468 | 328039 | 70565894 |
Hypocalcaemia | 59.40 | 18.84 | 90 | 34421 | 44769 | 70849164 |
Nasopharyngitis | 57.96 | 18.84 | 18 | 34493 | 222188 | 70671745 |
Acute myeloid leukaemia refractory | 57.33 | 18.84 | 13 | 34498 | 107 | 70893826 |
T-cell prolymphocytic leukaemia | 56.09 | 18.84 | 12 | 34499 | 73 | 70893860 |
Weight increased | 55.83 | 18.84 | 24 | 34487 | 242307 | 70651626 |
Condition aggravated | 54.78 | 18.84 | 77 | 34434 | 427558 | 70466375 |
Diffuse large B-cell lymphoma | 54.67 | 18.84 | 48 | 34463 | 13254 | 70880679 |
Drug hypersensitivity | 54.39 | 18.84 | 30 | 34481 | 262429 | 70631504 |
Chronic lymphocytic leukaemia transformation | 53.07 | 18.84 | 14 | 34497 | 227 | 70893706 |
Skin infection | 52.37 | 18.84 | 51 | 34460 | 16061 | 70877872 |
Hypogammaglobulinaemia | 52.23 | 18.84 | 44 | 34467 | 11494 | 70882439 |
Febrile bone marrow aplasia | 50.75 | 18.84 | 44 | 34467 | 11947 | 70881986 |
Aspergillus infection | 49.73 | 18.84 | 52 | 34459 | 17816 | 70876117 |
Dizziness | 49.70 | 18.84 | 94 | 34417 | 464047 | 70429886 |
Drug interaction | 49.52 | 18.84 | 68 | 34443 | 381373 | 70512560 |
Overdose | 49.49 | 18.84 | 11 | 34500 | 169734 | 70724199 |
Squamous cell carcinoma | 48.92 | 18.84 | 47 | 34464 | 14557 | 70879376 |
Lymphocyte count increased | 48.70 | 18.84 | 31 | 34480 | 5265 | 70888668 |
Transplant | 48.53 | 18.84 | 18 | 34493 | 924 | 70893009 |
Respiratory failure | 48.37 | 18.84 | 186 | 34325 | 168549 | 70725384 |
Synovitis | 47.91 | 18.84 | 4 | 34507 | 129224 | 70764709 |
Abdominal discomfort | 46.74 | 18.84 | 23 | 34488 | 214635 | 70679298 |
Drug ineffective | 46.60 | 18.84 | 268 | 34243 | 939484 | 69954449 |
Anxiety | 45.91 | 18.84 | 25 | 34486 | 220305 | 70673628 |
Leukaemia | 45.82 | 18.84 | 30 | 34481 | 5345 | 70888588 |
Minimal residual disease | 45.38 | 18.84 | 14 | 34497 | 406 | 70893527 |
Chronic lymphocytic leukaemia refractory | 44.39 | 18.84 | 11 | 34500 | 137 | 70893796 |
Maternal exposure during pregnancy | 44.38 | 18.84 | 3 | 34508 | 115342 | 70778591 |
Somnolence | 44.14 | 18.84 | 25 | 34486 | 215581 | 70678352 |
Asthma | 44.07 | 18.84 | 4 | 34507 | 120789 | 70773144 |
Urticaria | 42.88 | 18.84 | 13 | 34498 | 163036 | 70730897 |
Bone marrow transplant | 42.33 | 18.84 | 18 | 34493 | 1326 | 70892607 |
Depression | 42.30 | 18.84 | 22 | 34489 | 198952 | 70694981 |
Mantle cell lymphoma refractory | 41.92 | 18.84 | 10 | 34501 | 105 | 70893828 |
Blood uric acid increased | 41.71 | 18.84 | 35 | 34476 | 9094 | 70884839 |
Lymphocyte count decreased | 41.04 | 18.84 | 75 | 34436 | 43464 | 70850469 |
Hypoaesthesia | 40.90 | 18.84 | 12 | 34499 | 153727 | 70740206 |
Leukaemia recurrent | 40.75 | 18.84 | 22 | 34489 | 2753 | 70891180 |
Contraindicated product administered | 40.72 | 18.84 | 8 | 34503 | 134604 | 70759329 |
Therapeutic product effect decreased | 40.24 | 18.84 | 10 | 34501 | 143008 | 70750925 |
Tremor | 39.87 | 18.84 | 13 | 34498 | 155611 | 70738322 |
Inappropriate schedule of product administration | 38.08 | 18.84 | 4 | 34507 | 107551 | 70786382 |
Sinusitis fungal | 37.69 | 18.84 | 19 | 34492 | 2066 | 70891867 |
Klebsiella sepsis | 37.59 | 18.84 | 21 | 34490 | 2810 | 70891123 |
Infusion related reaction | 37.52 | 18.84 | 25 | 34486 | 197509 | 70696424 |
Peripheral swelling | 37.35 | 18.84 | 36 | 34475 | 236527 | 70657406 |
Gait disturbance | 37.12 | 18.84 | 22 | 34489 | 185084 | 70708849 |
Blood uric acid abnormal | 36.67 | 18.84 | 10 | 34501 | 185 | 70893748 |
Multiple organ dysfunction syndrome | 36.47 | 18.84 | 126 | 34385 | 108389 | 70785544 |
Hypersensitivity | 35.10 | 18.84 | 36 | 34475 | 229776 | 70664157 |
Transformation to acute myeloid leukaemia | 34.23 | 18.84 | 14 | 34497 | 935 | 70892998 |
Bone marrow failure | 33.68 | 18.84 | 74 | 34437 | 48936 | 70844997 |
Hyperkalaemia | 33.44 | 18.84 | 121 | 34390 | 106470 | 70787463 |
Hypophosphataemia | 32.62 | 18.84 | 40 | 34471 | 16286 | 70877647 |
Periorbital cellulitis | 32.55 | 18.84 | 13 | 34498 | 816 | 70893117 |
Cellulitis | 32.49 | 18.84 | 114 | 34397 | 98814 | 70795119 |
Pneumocystis jirovecii pneumonia | 32.47 | 18.84 | 55 | 34456 | 30027 | 70863906 |
Bacterial sepsis | 32.24 | 18.84 | 28 | 34483 | 7619 | 70886314 |
Blast cells | 30.80 | 18.84 | 5 | 34506 | 3 | 70893930 |
Insomnia | 30.11 | 18.84 | 37 | 34474 | 217769 | 70676164 |
Malaise | 29.99 | 18.84 | 109 | 34402 | 432823 | 70461110 |
Feeling abnormal | 29.85 | 18.84 | 16 | 34495 | 142303 | 70751630 |
Fungal sepsis | 29.27 | 18.84 | 15 | 34496 | 1688 | 70892245 |
Flushing | 29.23 | 18.84 | 3 | 34508 | 82169 | 70811764 |
Chest discomfort | 29.14 | 18.84 | 12 | 34499 | 124369 | 70769564 |
General physical health deterioration | 28.75 | 18.84 | 205 | 34306 | 235826 | 70658107 |
B-cell small lymphocytic lymphoma | 28.47 | 18.84 | 8 | 34503 | 166 | 70893767 |
Hospitalisation | 27.85 | 18.84 | 96 | 34415 | 82472 | 70811461 |
Wheezing | 27.65 | 18.84 | 6 | 34505 | 94164 | 70799769 |
Wound | 27.58 | 18.84 | 7 | 34504 | 98725 | 70795208 |
Erythema | 27.48 | 18.84 | 34 | 34477 | 199529 | 70694404 |
Systemic toxicity | 27.30 | 18.84 | 7 | 34504 | 101 | 70893832 |
Pleural effusion | 26.94 | 18.84 | 132 | 34379 | 132732 | 70761201 |
Respiratory tract infection | 26.88 | 18.84 | 62 | 34449 | 42336 | 70851597 |
Coronavirus infection | 26.58 | 18.84 | 23 | 34488 | 6229 | 70887704 |
Dyspnoea | 25.85 | 18.84 | 245 | 34266 | 769815 | 70124118 |
Hepatic enzyme increased | 25.82 | 18.84 | 23 | 34488 | 156967 | 70736966 |
White blood cell count abnormal | 25.52 | 18.84 | 21 | 34490 | 5309 | 70888624 |
Blood product transfusion dependent | 25.51 | 18.84 | 9 | 34502 | 400 | 70893533 |
Full blood count abnormal | 25.40 | 18.84 | 53 | 34458 | 33825 | 70860108 |
Cytomegalovirus colitis | 25.31 | 18.84 | 19 | 34492 | 4207 | 70889726 |
Epstein-Barr virus infection reactivation | 25.04 | 18.84 | 13 | 34498 | 1503 | 70892430 |
Cytomegalovirus infection reactivation | 24.97 | 18.84 | 23 | 34488 | 6758 | 70887175 |
Pseudomonal sepsis | 24.82 | 18.84 | 21 | 34490 | 5516 | 70888417 |
Muscle spasms | 24.82 | 18.84 | 23 | 34488 | 154023 | 70739910 |
Campylobacter gastroenteritis | 24.80 | 18.84 | 12 | 34499 | 1195 | 70892738 |
Treatment failure | 23.85 | 18.84 | 21 | 34490 | 144121 | 70749812 |
Seizure | 23.79 | 18.84 | 31 | 34480 | 177931 | 70716002 |
Anaphylactic reaction | 23.65 | 18.84 | 4 | 34507 | 74970 | 70818963 |
Pseudomonas infection | 23.58 | 18.84 | 37 | 34474 | 18957 | 70874976 |
Agitation | 23.56 | 18.84 | 8 | 34503 | 93367 | 70800566 |
Transfusion reaction | 23.55 | 18.84 | 13 | 34498 | 1700 | 70892233 |
Impaired healing | 23.39 | 18.84 | 4 | 34507 | 74370 | 70819563 |
Discomfort | 23.39 | 18.84 | 11 | 34500 | 105425 | 70788508 |
Wrong technique in product usage process | 23.21 | 18.84 | 3 | 34508 | 68695 | 70825238 |
Paraesthesia | 23.13 | 18.84 | 22 | 34489 | 145515 | 70748418 |
Phlebitis | 23.07 | 18.84 | 24 | 34487 | 8170 | 70885763 |
Stress | 22.88 | 18.84 | 3 | 34508 | 67963 | 70825970 |
Chest pain | 22.60 | 18.84 | 56 | 34455 | 251204 | 70642729 |
Plasma cell leukaemia | 22.48 | 18.84 | 13 | 34498 | 1858 | 70892075 |
Alopecia | 22.26 | 18.84 | 39 | 34472 | 198451 | 70695482 |
Bradycardia | 22.04 | 18.84 | 17 | 34494 | 124598 | 70769335 |
Angiodysplasia | 21.92 | 18.84 | 10 | 34501 | 872 | 70893061 |
Atypical pneumonia | 21.77 | 18.84 | 20 | 34491 | 5855 | 70888078 |
Refractory cancer | 21.66 | 18.84 | 7 | 34504 | 237 | 70893696 |
Herpes simplex | 21.60 | 18.84 | 27 | 34484 | 11205 | 70882728 |
Blister | 21.52 | 18.84 | 11 | 34500 | 100515 | 70793418 |
Chemotherapy | 21.49 | 18.84 | 12 | 34499 | 1604 | 70892329 |
Portal vein cavernous transformation | 21.38 | 18.84 | 6 | 34505 | 124 | 70893809 |
Drug intolerance | 21.32 | 18.84 | 49 | 34462 | 225638 | 70668295 |
Stem cell transplant | 21.21 | 18.84 | 16 | 34495 | 3569 | 70890364 |
Clostridium colitis | 21.09 | 18.84 | 14 | 34497 | 2552 | 70891381 |
Blood glucose increased | 20.98 | 18.84 | 12 | 34499 | 102970 | 70790963 |
Platelet disorder | 20.97 | 18.84 | 14 | 34497 | 2577 | 70891356 |
Terminal ileitis | 20.92 | 18.84 | 9 | 34502 | 682 | 70893251 |
Blastic plasmacytoid dendritic cell neoplasia | 20.81 | 18.84 | 6 | 34505 | 137 | 70893796 |
Pseudomonal skin infection | 20.73 | 18.84 | 4 | 34507 | 13 | 70893920 |
Pneumonia adenoviral | 20.64 | 18.84 | 8 | 34503 | 464 | 70893469 |
Balance disorder | 20.62 | 18.84 | 9 | 34502 | 90119 | 70803814 |
Colitis | 20.48 | 18.84 | 73 | 34438 | 63741 | 70830192 |
Migraine | 20.41 | 18.84 | 5 | 34506 | 72233 | 70821700 |
Splenic abscess | 20.10 | 18.84 | 8 | 34503 | 498 | 70893435 |
Vascular device infection | 19.93 | 18.84 | 22 | 34489 | 8008 | 70885925 |
Blast cell count decreased | 19.89 | 18.84 | 4 | 34507 | 17 | 70893916 |
Subdural haematoma | 19.86 | 18.84 | 44 | 34467 | 29254 | 70864679 |
Systemic candida | 19.69 | 18.84 | 19 | 34492 | 5915 | 70888018 |
Electrocardiogram QT prolonged | 19.65 | 18.84 | 8 | 34503 | 83509 | 70810424 |
Hyperhidrosis | 19.64 | 18.84 | 21 | 34490 | 131565 | 70762368 |
Haemolysis | 19.45 | 18.84 | 26 | 34485 | 11525 | 70882408 |
Hypercalcaemia | 19.34 | 18.84 | 48 | 34463 | 34337 | 70859596 |
Acute febrile neutrophilic dermatosis | 19.27 | 18.84 | 15 | 34496 | 3504 | 70890429 |
Escherichia infection | 19.16 | 18.84 | 31 | 34480 | 16300 | 70877633 |
Haematotoxicity | 18.90 | 18.84 | 28 | 34483 | 13646 | 70880287 |
Haematochezia | 18.90 | 18.84 | 6 | 34505 | 73075 | 70820858 |
None
Source | Code | Description |
---|---|---|
ATC | L01XX52 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
FDA PE | N0000009176 | Increased Cellular Death |
MeSH PA | D000970 | Antineoplastic Agents |
FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
FDA EPC | N0000192515 | BCL-2 Inhibitor |
CHEBI has role | CHEBI:35610 | antineoplastic agents |
CHEBI has role | CHEBI:68495 | Type I cell-death inducers |
CHEBI has role | CHEBI:133022 | B-cell lymphoma 2 inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Acute myeloid leukemia, disease | indication | 91861009 | |
Chronic lymphoid leukemia, disease | indication | 92814006 | |
Malignant lymphoma - small lymphocytic | indication | 302841002 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 2.0 | acidic |
pKa2 | 13.01 | acidic |
pKa3 | 7.73 | Basic |
pKa4 | 4.24 | Basic |
pKa5 | 3.47 | Basic |
pKa6 | 0.56 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9174982 | May 26, 2030 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 10993942 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11413282 | Sept. 6, 2033 | TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 10993942 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11413282 | Sept. 6, 2033 | TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 10993942 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11110087 | Sept. 6, 2033 | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 11413282 | Sept. 6, 2033 | TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | 9539251 | Sept. 6, 2033 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2026 | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Apoptosis regulator Bcl-2 | Cytosolic other | INHIBITOR | Ki | 11 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Aspartyl/asparaginyl beta-hydroxylase | Enzyme | IC50 | 5.89 | CHEMBL | |||||
Bcl-2-like protein 1 | Cytosolic other | INHIBITOR | Ki | 7.32 | SCIENTIFIC LITERATURE | ||||
Apoptosis regulator Bcl-W | Cytosolic other | INHIBITOR | Ki | 6.61 | SCIENTIFIC LITERATURE |
ID | Source |
---|---|
N54AIC43PW | UNII |
D10679 | KEGG_DRUG |
C4079830 | UMLSCUI |
CHEBI:133021 | CHEBI |
LBM | PDB_CHEM_ID |
CHEMBL3137309 | ChEMBL_ID |
49846579 | PUBCHEM_CID |
DB11581 | DRUGBANK_ID |
9925 | INN_ID |
C579720 | MESH_SUPPLEMENTAL_RECORD_UI |
8318 | IUPHAR_LIGAND_ID |
1747556 | RXNORM |
240227 | MMSL |
31601 | MMSL |
d08429 | MMSL |
016803 | NDDF |
720491001 | SNOMEDCT_US |
763511000 | SNOMEDCT_US |
4035629 | VANDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0561 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0561 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0566 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 32 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0566 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 32 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0576 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0576 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |