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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127296501 | 12729650 | 1 | I | 20160905 | 20160909 | 20160909 | EXP | US-OTSUKA-2016_021559 | OTSUKA | NIETO Y, VALDEZ BC, THALL PF, JONES RB, WEI W, MYERS A ET AL. DOUBLE EPIGENETIC MODULATION OF HIGH-DOSE CHEMOTHERAPY WITH AZACITIDINE AND VORINOSTAT FOR PATIENTS WITH REFRACTORY OR POOR-RISK RELAPSED LYMPHOMA. CANCER. 2016;122(17):2680-8 | 0.00 | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127296501 | 12729650 | 1 | PS | BUSULFEX | BUSULFAN | 1 | Intravenous (not otherwise specified) | UNK, OVER THREE HOURS (QD) (ON DAYS -8 THROUGH -5) | 20955 | INJECTION | |||||||||
| 127296501 | 12729650 | 2 | SS | BUSULFEX | BUSULFAN | 1 | Intravenous (not otherwise specified) | 32 MG/M2, OVER 60 MINUTES (TEST DOSE) | 20955 | 32 | MG/M**2 | INJECTION | |||||||
| 127296501 | 12729650 | 3 | SS | AZACITIDINE. | AZACITIDINE | 1 | Intravenous (not otherwise specified) | 35 MG/M2, QD AT LEVEL 3 (-11 THROUGH -2 DAYS) | 0 | 35 | MG/M**2 | QD | |||||||
| 127296501 | 12729650 | 4 | SS | AZACITIDINE. | AZACITIDINE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, QD AT LEVEL 1 (-11 THROUGH -2 DAYS) | 0 | 15 | MG/M**2 | QD | |||||||
| 127296501 | 12729650 | 5 | SS | AZACITIDINE. | AZACITIDINE | 1 | Intravenous (not otherwise specified) | 25 MG/M2, QD AT LEVEL 2 (-11 THROUGH -2 DAYS) | 0 | 25 | MG/M**2 | QD | |||||||
| 127296501 | 12729650 | 6 | SS | VORINOSTAT | VORINOSTAT | 1 | Oral | 1000 MG, QD (-11 THROUGH -2 DAYS) | 0 | 1000 | MG | QD | |||||||
| 127296501 | 12729650 | 7 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2775 MG/M2 (ON DAYS -3 AND -8) | 0 | 2775 | MG/M**2 | ||||||||
| 127296501 | 12729650 | 8 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | 60 MG/M2, QD (OVER 30 MINUTES ON DAYS -3 AND -2) | 0 | 60 | MG/M**2 | QD | |||||||
| 127296501 | 12729650 | 9 | C | PHENYTOIN. | PHENYTOIN | 1 | Unknown | 300 TO 600 MG, QD ON DAYS -9 THROUGH -2 | 0 | QD | |||||||||
| 127296501 | 12729650 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 8 MG, BID ON DAYS -11 THROUGH -2 | 0 | 8 | MG | BID | |||||||
| 127296501 | 12729650 | 11 | C | PALIFERMIN | PALIFERMIN | 1 | Oral | UNK | 0 | ||||||||||
| 127296501 | 12729650 | 12 | C | GLUTAMINE | GLUTAMINE | 1 | Oral | UNK | 0 | ||||||||||
| 127296501 | 12729650 | 13 | C | CALCIUM PHOSPHATE | CALCIUM PHOSPHATE | 1 | Oral | UNK, SUPERSATURATED RINSE | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127296501 | 12729650 | 1 | Stem cell transplant |
| 127296501 | 12729650 | 3 | Stem cell transplant |
| 127296501 | 12729650 | 6 | Stem cell transplant |
| 127296501 | 12729650 | 7 | Stem cell transplant |
| 127296501 | 12729650 | 8 | Stem cell transplant |
| 127296501 | 12729650 | 9 | Supportive care |
| 127296501 | 12729650 | 10 | Supportive care |
| 127296501 | 12729650 | 11 | Supportive care |
| 127296501 | 12729650 | 12 | Supportive care |
| 127296501 | 12729650 | 13 | Supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127296501 | 12729650 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127296501 | 12729650 | Norovirus test positive | |
| 127296501 | 12729650 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |