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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426881 | 12542688 | 1 | I | 20131023 | 20160628 | 20160709 | 20160709 | EXP | US-BAXTER-2016BAX034996 | BAXTER | 46.00 | YR | F | Y | 0.00000 | 20160709 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426881 | 12542688 | 1 | PS | VANCOMYCIN INJECTION, USP | VANCOMYCIN | 1 | Unknown | REGIMEN #1 | 50671 | SOLUTION FOR INFUSION | /cycle | ||||||||
| 125426881 | 12542688 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 60 | MG | QD | ||||||||
| 125426881 | 12542688 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | REGIMEN #1, 2 MG/KG, UNRESPONSIVE | 0 | 120 | MG | QD | |||||||
| 125426881 | 12542688 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | REGIMEN #2 | 0 | /cycle | |||||||||
| 125426881 | 12542688 | 5 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | INFUSION, REGIMEN #1 | 0 | /cycle | |||||||||
| 125426881 | 12542688 | 6 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | REGIMEN #1 | 0 | /cycle | |||||||||
| 125426881 | 12542688 | 7 | SS | morphine | MORPHINE | 1 | Unknown | REGIMEN #1 | 0 | /cycle | |||||||||
| 125426881 | 12542688 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Unknown | REGIMEN #1 | 0 | /cycle | |||||||||
| 125426881 | 12542688 | 9 | SS | cyclosporin | CYCLOSPORINE | 1 | Unknown | INFUSION | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426881 | 12542688 | 1 | Product used for unknown indication |
| 125426881 | 12542688 | 2 | Acute graft versus host disease |
| 125426881 | 12542688 | 3 | Acute graft versus host disease |
| 125426881 | 12542688 | 5 | Prophylaxis against graft versus host disease |
| 125426881 | 12542688 | 6 | Product used for unknown indication |
| 125426881 | 12542688 | 7 | Product used for unknown indication |
| 125426881 | 12542688 | 8 | Product used for unknown indication |
| 125426881 | 12542688 | 9 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125426881 | 12542688 | HO |
| 125426881 | 12542688 | OT |
| 125426881 | 12542688 | LT |
| 125426881 | 12542688 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426881 | 12542688 | Atrial fibrillation | |
| 125426881 | 12542688 | Condition aggravated | |
| 125426881 | 12542688 | Cytomegalovirus colitis | |
| 125426881 | 12542688 | Gastrointestinal haemorrhage | |
| 125426881 | 12542688 | Graft versus host disease in gastrointestinal tract | |
| 125426881 | 12542688 | Hypotension | |
| 125426881 | 12542688 | Infection | |
| 125426881 | 12542688 | Melaena | |
| 125426881 | 12542688 | Multiple organ dysfunction syndrome | |
| 125426881 | 12542688 | Pancytopenia | |
| 125426881 | 12542688 | Plasma cell myeloma | |
| 125426881 | 12542688 | Pulmonary oedema | |
| 125426881 | 12542688 | Staphylococcal bacteraemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125426881 | 12542688 | 2 | 20160422 | 20160426 | 0 | |
| 125426881 | 12542688 | 3 | 20160426 | 20160509 | 0 | |
| 125426881 | 12542688 | 4 | 20160510 | 0 | ||
| 125426881 | 12542688 | 5 | 20160425 | 0 | ||
| 125426881 | 12542688 | 9 | 20160425 | 20160509 | 0 |