Stem definition | Drug id | CAS RN |
---|---|---|
chimeric origin | 4948 | 1363687-32-4 |
Molecule | Description |
---|---|
Synonyms:
|
a human-mouse chimeric monoclonal antibody directed against disialoganglioside (GD2); used for treatment of refractory neuroblastoma & osteosarcoma
|
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
June 23, 2021 | PMDA | OHARA PHARMACEUTICAL Co.,Ltd. | |
Aug. 14, 2015 | EMA | United Therapeutics Europe Ltd | |
March 10, 2015 | FDA | UNITED THERAP |
None
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 |
---|---|---|---|---|---|---|
Thrombotic microangiopathy | 53.20 | 45.62 | 16 | 723 | 8665 | 29565123 |
Cardiotoxicity | 53.05 | 45.62 | 14 | 725 | 4730 | 29569058 |
Pyrexia | 45.73 | 45.62 | 45 | 694 | 287577 | 29286211 |
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 |
---|---|---|---|---|---|---|
Pyrexia | 72.09 | 39.26 | 72 | 1275 | 558572 | 63938813 |
Myelitis transverse | 58.52 | 39.26 | 12 | 1335 | 1611 | 64495774 |
Thrombotic microangiopathy | 49.57 | 39.26 | 17 | 1330 | 16638 | 64480747 |
Cardiotoxicity | 44.78 | 39.26 | 14 | 1333 | 10260 | 64487125 |
Pancytopenia | 44.76 | 39.26 | 31 | 1316 | 143278 | 64354107 |
Neuroblastoma recurrent | 43.77 | 39.26 | 6 | 1341 | 66 | 64497319 |
Hypoxia | 42.26 | 39.26 | 25 | 1322 | 88124 | 64409261 |
None
Source | Code | Description |
---|---|---|
MeSH PA | D000970 | Antineoplastic Agents |
FDA MoA | N0000191499 | Glycolipid Disialoganglioside-directed Antibody Interactions |
FDA EPC | N0000191500 | Glycolipid Disialoganglioside-directed Antibody |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Neuroblastoma | indication | 432328008 | DOID:769 |
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ID | Source |
---|---|
D10559 | KEGG_DRUG |
4034568 | VUID |
N0000191732 | NUI |
4034568 | VANDF |
CHEMBL2109420 | ChEMBL_ID |
CHEMBL3137342 | ChEMBL_ID |
C112746 | MESH_SUPPLEMENTAL_RECORD_UI |
7979 | IUPHAR_LIGAND_ID |
9754 | INN_ID |
DB09077 | DRUGBANK_ID |
7SQY4ZUD30 | UNII |
1606274 | RXNORM |
233210 | MMSL |
30928 | MMSL |
d08351 | MMSL |
724036009 | SNOMEDCT_US |
763590003 | SNOMEDCT_US |
C0281581 | UMLSCUI |
016047 | NDDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Unituxin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-014 | INJECTION | 3.50 mg | INTRAVENOUS | BLA | 32 sections |
Unituxin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-014 | INJECTION | 3.50 mg | INTRAVENOUS | BLA | 32 sections |