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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125821131 | 12582113 | 1 | I | 20160708 | 20160722 | 20160722 | EXP | US-CIPLA LTD.-2016US09766 | CIPLA | ANDERLINI P, SALIBA RM, LEDESMA C, PLAIR T, ALOUSI AM, HOSING CM ET AL.,. GEMCITABINE, FLUDARABINE, AND MELPHALAN FOR REDUCED-INTENSITY CONDITIONING AND ALLOGENEIC STEM CELL TRANSPLANTATION FOR RELAPSED AND REFRACTORY HODGKIN LYMPHOMA. BIOL BLOOD MARROW TRANSPLANT. 2016;22:1324 TO 1340 | 0.00 | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125821131 | 12582113 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, QD, OVER 30 MINUTES ONE TIME AT DAY 7 | U | U | 78759 | 800 | MG/M**2 | ||||||
| 125821131 | 12582113 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 33 MG/M2, QID,FROM DAY -5 TO DAY -2 | U | U | 0 | 33 | MG/M**2 | ||||||
| 125821131 | 12582113 | 3 | SS | Melphalan | MELPHALAN | 1 | Intravenous (not otherwise specified) | 70 MG/M2, BID, FROM DAY - 3 TO - 2 | U | U | 0 | 70 | MG/M**2 | ||||||
| 125821131 | 12582113 | 4 | SS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 2 MG/KG, BID | U | U | 0 | 2 | MG/KG | ||||||
| 125821131 | 12582113 | 5 | C | TACROLIMUS. | TACROLIMUS | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 | ||||||||
| 125821131 | 12582113 | 6 | C | TACROLIMUS. | TACROLIMUS | 1 | Oral | UNK | U | U | 0 | ||||||||
| 125821131 | 12582113 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5 MG/M2, UNK, ON DAYS 1, 3, 6, AND 11 AFTER TRANSPLANT | U | U | 0 | 5 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125821131 | 12582113 | 1 | Hodgkin's disease |
| 125821131 | 12582113 | 2 | Hodgkin's disease |
| 125821131 | 12582113 | 3 | Hodgkin's disease |
| 125821131 | 12582113 | 4 | Hodgkin's disease |
| 125821131 | 12582113 | 5 | Prophylaxis |
| 125821131 | 12582113 | 7 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125821131 | 12582113 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125821131 | 12582113 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |