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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125329651 | 12532965 | 1 | I | 20160510 | 20160628 | 20160706 | 20160706 | EXP | US-PURDUE-USA-2016-0131948 | PURDUE | 46.00 | YR | F | Y | 0.00000 | 20160706 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125329651 | 12532965 | 1 | PS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0.5-1 MG, Q4H PRN | U | U | UNKNOWN | 19034 | .5 | MG | INJECTION | ||||
| 125329651 | 12532965 | 2 | SS | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | 2 MG, PRN | U | U | UNKNOWN | 0 | 2 | MG | |||||
| 125329651 | 12532965 | 3 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | U | U | UNKNOWN | 0 | ||||||||
| 125329651 | 12532965 | 4 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | U | U | UNKNOWN | 0 | ||||||||
| 125329651 | 12532965 | 5 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | U | U | UNKNOWN | 0 | |||||||
| 125329651 | 12532965 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | UNK | 1680 | MG | U | U | UNKNOWN | 0 | |||||
| 125329651 | 12532965 | 7 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 120 MG, DAILY | 1680 | MG | U | U | UNKNOWN | 0 | 120 | MG | |||
| 125329651 | 12532965 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 60 MG, DAILY | 300 | MG | U | U | UNKNOWN | 0 | 60 | MG | |||
| 125329651 | 12532965 | 9 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | U | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125329651 | 12532965 | 1 | Product used for unknown indication |
| 125329651 | 12532965 | 2 | Product used for unknown indication |
| 125329651 | 12532965 | 3 | Product used for unknown indication |
| 125329651 | 12532965 | 4 | Product used for unknown indication |
| 125329651 | 12532965 | 5 | Prophylaxis against graft versus host disease |
| 125329651 | 12532965 | 6 | Graft versus host disease |
| 125329651 | 12532965 | 8 | Acute graft versus host disease |
| 125329651 | 12532965 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125329651 | 12532965 | HO |
| 125329651 | 12532965 | DE |
| 125329651 | 12532965 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125329651 | 12532965 | Acute kidney injury | |
| 125329651 | 12532965 | Hypotension | |
| 125329651 | 12532965 | Infection | |
| 125329651 | 12532965 | Melaena | |
| 125329651 | 12532965 | Multiple organ dysfunction syndrome | |
| 125329651 | 12532965 | Pancytopenia | |
| 125329651 | 12532965 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 125329651 | 12532965 | 5 | 20160425 | 0 | ||
| 125329651 | 12532965 | 6 | 20160510 | 0 | ||
| 125329651 | 12532965 | 7 | 20160426 | 20160509 | 0 | |
| 125329651 | 12532965 | 8 | 20160422 | 20160426 | 0 | |
| 125329651 | 12532965 | 9 | 20160425 | 20160509 | 0 |