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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125687011 | 12568701 | 1 | I | 20160502 | 20160706 | 20160719 | 20160719 | EXP | US-ROCHE-1791689 | ROCHE | 46.00 | YR | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125687011 | 12568701 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 50722 | ||||||||||
| 125687011 | 12568701 | 2 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | U | 19661 | ||||||||||
| 125687011 | 12568701 | 3 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | U | 0 | ||||||||||
| 125687011 | 12568701 | 4 | SS | MORPHINE | MORPHINE | 1 | Unknown | U | 0 | ||||||||||
| 125687011 | 12568701 | 5 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0.5-1 MG EVERY 4 HOURS AS NEEDED (PRN) | U | 0 | |||||||||
| 125687011 | 12568701 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 125687011 | 12568701 | 7 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | 0 | 2 | MG/KG | ||||||||
| 125687011 | 12568701 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | QD | |||||||||
| 125687011 | 12568701 | 9 | SS | CYCLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR TO SAE: 09/MAY/2016 | U | 0 | INFUSION | ||||||||
| 125687011 | 12568701 | 10 | SS | INCB039110 | INVESTIGATIONAL PRODUCT | 1 | Oral | MOST RECENT DOSE PRIOR TO SAE: 09/MAY/2016 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125687011 | 12568701 | 1 | Prophylaxis against graft versus host disease |
| 125687011 | 12568701 | 2 | Product used for unknown indication |
| 125687011 | 12568701 | 3 | Product used for unknown indication |
| 125687011 | 12568701 | 4 | Product used for unknown indication |
| 125687011 | 12568701 | 5 | Product used for unknown indication |
| 125687011 | 12568701 | 6 | Graft versus host disease |
| 125687011 | 12568701 | 8 | Graft versus host disease |
| 125687011 | 12568701 | 9 | Prophylaxis against graft versus host disease |
| 125687011 | 12568701 | 10 | Graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125687011 | 12568701 | DE |
| 125687011 | 12568701 | HO |
| 125687011 | 12568701 | LT |
| 125687011 | 12568701 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125687011 | 12568701 | Acidosis | |
| 125687011 | 12568701 | Acute kidney injury | |
| 125687011 | 12568701 | Atrial fibrillation | |
| 125687011 | 12568701 | Hypotension | |
| 125687011 | 12568701 | Immunosuppressant drug level increased | |
| 125687011 | 12568701 | Infection | |
| 125687011 | 12568701 | Melaena | |
| 125687011 | 12568701 | Multiple organ dysfunction syndrome | |
| 125687011 | 12568701 | Pancytopenia | |
| 125687011 | 12568701 | Pulmonary oedema | |
| 125687011 | 12568701 | Respiratory failure | |
| 125687011 | 12568701 | Thrombocytopenia | |
| 125687011 | 12568701 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125687011 | 12568701 | 1 | 20160425 | 0 | ||
| 125687011 | 12568701 | 4 | 20160510 | 0 | ||
| 125687011 | 12568701 | 5 | 20160510 | 0 | ||
| 125687011 | 12568701 | 6 | 20160426 | 20160509 | 0 | |
| 125687011 | 12568701 | 8 | 20160422 | 20160426 | 0 | |
| 125687011 | 12568701 | 9 | 20160425 | 0 | ||
| 125687011 | 12568701 | 10 | 20160505 | 0 |