| Stem definition | Drug id | CAS RN |
|---|---|---|
| blood factor IX | 5084 | 1270012-74-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
consists of factor IX fused to the Fc fragment of human IgG1
|
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 12, 2016 | EMA | Swedish Orphan Biovitrum AB |
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 |
|---|---|---|---|---|---|---|
| Haemorrhage | 1024.66 | 68.47 | 258 | 1098 | 51112 | 34904463 |
| Haemarthrosis | 374.12 | 68.47 | 70 | 1286 | 3189 | 34952386 |
| Factor IX inhibition | 175.89 | 68.47 | 23 | 1333 | 82 | 34955493 |
| Spontaneous haemorrhage | 157.84 | 68.47 | 24 | 1332 | 296 | 34955279 |
| Traumatic haemorrhage | 96.89 | 68.47 | 18 | 1338 | 773 | 34954802 |
| Contusion | 95.76 | 68.47 | 40 | 1316 | 36324 | 34919251 |
| Muscle haemorrhage | 93.99 | 68.47 | 23 | 1333 | 3695 | 34951880 |
| 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 |
|---|---|---|---|---|---|---|
| Haemorrhage | 932.42 | 61.24 | 222 | 968 | 90896 | 79652302 |
| Haemarthrosis | 360.48 | 61.24 | 64 | 1126 | 5748 | 79737450 |
| Spontaneous haemorrhage | 150.71 | 61.24 | 23 | 1167 | 794 | 79742404 |
| Factor IX inhibition | 144.09 | 61.24 | 17 | 1173 | 71 | 79743127 |
| Muscle haemorrhage | 103.81 | 61.24 | 23 | 1167 | 6277 | 79736921 |
| Traumatic haemorrhage | 84.50 | 61.24 | 15 | 1175 | 1318 | 79741880 |
| Contusion | 75.57 | 61.24 | 39 | 1151 | 148737 | 79594461 |
None
None
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hereditary factor IX deficiency disease | indication | 41788008 | DOID:12259 |
None
None
None
None
None
None
| ID | Source |
|---|---|
| 02E00T2QDE | UNII |
| D10522 | KEGG_DRUG |
| C3818700 | UMLSCUI |
| CHEMBL4594598 | ChEMBL_ID |
| DB11608 | DRUGBANK_ID |
| 9660 | INN_ID |
| C000599709 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1535944 | RXNORM |
| 220196 | MMSL |
| 718942000 | SNOMEDCT_US |
None