Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121093804 | 12109380 | 4 | F | 20160818 | 20160224 | 20160826 | EXP | CA-AMGEN-CANSP2016020166 | AMGEN | 10.00 | YR | C | F | Y | 0.00000 | 20160826 | OT | CA | CA |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121093804 | 12109380 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 121093804 | 12109380 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 121093804 | 12109380 | 3 | SS | APO MYCOPHENOLATE | MYCOPHENOLIC ACID | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 4 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 5 | SS | RITUXAN | RITUXIMAB | 1 | 0 | ||||||||||||
| 121093804 | 12109380 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | 0 | CAPSULE | |||||||||
| 121093804 | 12109380 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | 0 | CAPSULE | |||||||||||
| 121093804 | 12109380 | 8 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 9 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 10 | SS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 11 | C | BETAMETHASONE. | BETAMETHASONE | 1 | Oral | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 12 | SS | BUDESONIDE. | BUDESONIDE | 1 | Oral | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 13 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 1.0 MG/KG, QD | 0 | 1 | MG/KG | QD | |||||||
| 121093804 | 12109380 | 14 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intra-arterial | 3 MG/KG, QD | 0 | 3 | MG/KG | QD | |||||||
| 121093804 | 12109380 | 15 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 2 MG/KG, UNK | 0 | 2 | MG/KG | ||||||||
| 121093804 | 12109380 | 16 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 1.0 MG/KG, QD | 0 | 1 | MG/KG | QD | |||||||
| 121093804 | 12109380 | 17 | SS | RAPAMUNE | SIROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 121093804 | 12109380 | 18 | SS | RAPAMUNE | SIROLIMUS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121093804 | 12109380 | 1 | Immunosuppression |
| 121093804 | 12109380 | 2 | Graft versus host disease |
| 121093804 | 12109380 | 3 | Graft versus host disease |
| 121093804 | 12109380 | 4 | Immunosuppression |
| 121093804 | 12109380 | 5 | Graft versus host disease |
| 121093804 | 12109380 | 6 | Immunosuppression |
| 121093804 | 12109380 | 7 | Graft versus host disease |
| 121093804 | 12109380 | 8 | Graft versus host disease |
| 121093804 | 12109380 | 9 | Graft versus host disease |
| 121093804 | 12109380 | 10 | Immunosuppression |
| 121093804 | 12109380 | 12 | Immunosuppression |
| 121093804 | 12109380 | 13 | Graft versus host disease |
| 121093804 | 12109380 | 17 | Immunosuppression |
| 121093804 | 12109380 | 18 | Graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121093804 | 12109380 | DE |
| 121093804 | 12109380 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121093804 | 12109380 | Adenovirus infection | |
| 121093804 | 12109380 | Cytomegalovirus infection | |
| 121093804 | 12109380 | Graft versus host disease | |
| 121093804 | 12109380 | Graft versus host disease in gastrointestinal tract | |
| 121093804 | 12109380 | Graft versus host disease in skin | |
| 121093804 | 12109380 | Human herpesvirus 6 infection | |
| 121093804 | 12109380 | Pneumocystis jirovecii pneumonia | |
| 121093804 | 12109380 | Product use issue | |
| 121093804 | 12109380 | Pseudomonas infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |