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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125412632 | 12541263 | 2 | F | 2016 | 20160812 | 20160708 | 20160822 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-2016-RO-01052RO | WESTWARD | 46.00 | YR | F | Y | 88.00000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125412632 | 12541263 | 1 | PS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | 76222 | |||||||||||
| 125412632 | 12541263 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 202691 | 2 | MG/KG | |||||||||
| 125412632 | 12541263 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 202691 | 120 | MG | QD | ||||||||
| 125412632 | 12541263 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 202691 | |||||||||||
| 125412632 | 12541263 | 5 | SS | MORPHINE | MORPHINE | 1 | Unknown | 205758 | |||||||||||
| 125412632 | 12541263 | 6 | SS | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | 205758 | 2 | MG | |||||||||
| 125412632 | 12541263 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 80352 | 60 | MG | QD | ||||||||
| 125412632 | 12541263 | 8 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | 62682 | |||||||||||
| 125412632 | 12541263 | 9 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Intravenous drip | 65004 | |||||||||||
| 125412632 | 12541263 | 10 | SS | INCB039110 | INVESTIGATIONAL PRODUCT | 1 | Oral | 200 MG | 0 | 200 | MG | QD | |||||||
| 125412632 | 12541263 | 11 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 125412632 | 12541263 | 12 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | Q4H | ||||||||||
| 125412632 | 12541263 | 13 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2000 MG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125412632 | 12541263 | 1 | Product used for unknown indication |
| 125412632 | 12541263 | 2 | Graft versus host disease in gastrointestinal tract |
| 125412632 | 12541263 | 5 | Product used for unknown indication |
| 125412632 | 12541263 | 7 | Graft versus host disease in gastrointestinal tract |
| 125412632 | 12541263 | 8 | Product used for unknown indication |
| 125412632 | 12541263 | 9 | Prophylaxis against graft versus host disease |
| 125412632 | 12541263 | 10 | Graft versus host disease in gastrointestinal tract |
| 125412632 | 12541263 | 11 | Product used for unknown indication |
| 125412632 | 12541263 | 13 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125412632 | 12541263 | DE |
| 125412632 | 12541263 | HO |
| 125412632 | 12541263 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125412632 | 12541263 | Acute kidney injury | |
| 125412632 | 12541263 | Atrial fibrillation | |
| 125412632 | 12541263 | Disease progression | |
| 125412632 | 12541263 | Graft versus host disease in gastrointestinal tract | |
| 125412632 | 12541263 | Multiple organ dysfunction syndrome | |
| 125412632 | 12541263 | Staphylococcal infection | |
| 125412632 | 12541263 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 125412632 | 12541263 | 3 | 20160426 | 20160509 | 0 | |
| 125412632 | 12541263 | 4 | 20160510 | 0 | ||
| 125412632 | 12541263 | 6 | 20160510 | 0 | ||
| 125412632 | 12541263 | 7 | 20160422 | 20160426 | 0 | |
| 125412632 | 12541263 | 9 | 20160425 | 20160509 | 0 | |
| 125412632 | 12541263 | 10 | 20160505 | 20160509 | 0 | |
| 125412632 | 12541263 | 12 | 20160510 | 0 | ||
| 125412632 | 12541263 | 13 | 20160425 | 0 |