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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126869741 | 12686974 | 1 | I | 201601 | 20160816 | 20160826 | 20160826 | EXP | FR-BAXTER-2016BAX043216 | BAXTER | 63.70 | YR | M | Y | 76.00000 | KG | 20160825 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126869741 | 12686974 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 1 | 12142 | 1450 | MG | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 2 | SS | doxorubicine Teva | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | STRENGTH 200 MG/100 ML, IV (INFUSION), DAY 1 | 0 | 97 | MG | SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 3 | SS | vincristine Hospira | VINCRISTINE | 1 | Intravenous (not otherwise specified) | STRENGTH 2 MG/2 ML, IV (INFUSION), DAY 1 | 0 | 2 | MG | SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 4 | SS | etoposide Teva | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | SOLUTION FOR DILUTION FOR INFUSION, DAY 2 | 0 | 190 | MG | /cycle | |||||||
| 126869741 | 12686974 | 5 | SS | etoposide Teva | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | SOLUTION FOR DILUTION FOR INFUSION, DAY 3 | 0 | 190 | MG | /cycle | |||||||
| 126869741 | 12686974 | 6 | SS | Cortancyl | PREDNISONE | 1 | Oral | DAY 4 | 0 | 115 | MG | /cycle | |||||||
| 126869741 | 12686974 | 7 | SS | Cortancyl | PREDNISONE | 1 | Oral | DAY 5 | 0 | 115 | MG | /cycle | |||||||
| 126869741 | 12686974 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | DAY 1 | 0 | /cycle | |||||||||
| 126869741 | 12686974 | 9 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 1 | 0 | 100 | MG | /cycle | |||||||
| 126869741 | 12686974 | 10 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 2 | 0 | 100 | MG | /cycle | |||||||
| 126869741 | 12686974 | 11 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 3 | 0 | 100 | MG | /cycle | |||||||
| 126869741 | 12686974 | 12 | SS | ondansetron Accord | ONDANSETRON | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 1 | 0 | 8 | MG | SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 13 | SS | ondansetron Accord | ONDANSETRON | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 2 | 0 | 8 | MG | SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 14 | SS | ondansetron Accord | ONDANSETRON | 1 | Intravenous (not otherwise specified) | IV (INFUSION), DAY 3 | 0 | 8 | MG | SOLUTION FOR INJECTION | /cycle | ||||||
| 126869741 | 12686974 | 15 | SS | Granocyte | LENOGRASTIM | 1 | Unknown | FROM DAY 6 TO DAY 12 | 0 | ||||||||||
| 126869741 | 12686974 | 16 | C | Zelitrex | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126869741 | 12686974 | 17 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | |||||||||||
| 126869741 | 12686974 | 18 | C | Lederfoline | LEUCOVORIN CALCIUM | 1 | Oral | 0 | 25 | MG | /wk | ||||||||
| 126869741 | 12686974 | 19 | C | Zyloric | ALLOPURINOL | 1 | Oral | 0 | 100 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126869741 | 12686974 | 1 | Peripheral T-cell lymphoma unspecified stage II |
| 126869741 | 12686974 | 2 | Peripheral T-cell lymphoma unspecified stage II |
| 126869741 | 12686974 | 3 | Peripheral T-cell lymphoma unspecified stage II |
| 126869741 | 12686974 | 4 | Peripheral T-cell lymphoma unspecified stage II |
| 126869741 | 12686974 | 6 | Peripheral T-cell lymphoma unspecified stage II |
| 126869741 | 12686974 | 8 | Product used for unknown indication |
| 126869741 | 12686974 | 9 | Product used for unknown indication |
| 126869741 | 12686974 | 12 | Product used for unknown indication |
| 126869741 | 12686974 | 15 | Product used for unknown indication |
| 126869741 | 12686974 | 16 | Prophylaxis |
| 126869741 | 12686974 | 17 | Prophylaxis |
| 126869741 | 12686974 | 18 | Prophylaxis |
| 126869741 | 12686974 | 19 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126869741 | 12686974 | HO |
| 126869741 | 12686974 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126869741 | 12686974 | Acute prerenal failure | |
| 126869741 | 12686974 | Cardiac arrest | |
| 126869741 | 12686974 | Diarrhoea | |
| 126869741 | 12686974 | Escherichia sepsis | |
| 126869741 | 12686974 | Febrile bone marrow aplasia | |
| 126869741 | 12686974 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 126869741 | 12686974 | 1 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 2 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 3 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 4 | 20160107 | 20160107 | 0 | |
| 126869741 | 12686974 | 5 | 20160108 | 20160108 | 0 | |
| 126869741 | 12686974 | 6 | 20160109 | 20160109 | 0 | |
| 126869741 | 12686974 | 7 | 20160110 | 20160110 | 0 | |
| 126869741 | 12686974 | 8 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 9 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 10 | 20160107 | 20160107 | 0 | |
| 126869741 | 12686974 | 11 | 20160108 | 20160108 | 0 | |
| 126869741 | 12686974 | 12 | 20160106 | 20160106 | 0 | |
| 126869741 | 12686974 | 13 | 20160107 | 20160107 | 0 | |
| 126869741 | 12686974 | 14 | 20160108 | 20160108 | 0 | |
| 126869741 | 12686974 | 15 | 20160111 | 20160117 | 0 |