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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126899601 | 12689960 | 1 | I | 20160116 | 20160816 | 20160826 | 20160826 | EXP | FR-TEVA-686575ROM | TEVA | 63.74 | YR | M | Y | 76.00000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126899601 | 12689960 | 1 | PS | DOXORUBICINE TEVA 200 mg/100 ml | DOXORUBICIN | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 1 | 63097 | 97 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 2 | SS | ETOPOSIDE TEVA 20 mg/ml | ETOPOSIDE | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 2 AND DAY 3 | 74284 | 190 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | CHOEP 21 PROTOCOL, DAY 1 | 81099 | SOLUTION FOR INJECTION | |||||||||
| 126899601 | 12689960 | 4 | SS | ENDOXAN 1000 mg | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 1 | 0 | 1450 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 5 | SS | vincristine HOSPIRA 2 mg/2 ml | VINCRISTINE | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 1 | 0 | 2 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 6 | SS | METHYLPREDNISOLONE MYLAN | METHYLPREDNISOLONE | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 1, DAY 2 AND DAY 3 | 0 | 100 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 7 | SS | CORTANCYL | PREDNISONE | 1 | Oral | CHOEP 21 PROTOCOL, DAY 4 AND DAY 5 | 0 | 115 | MG | ||||||||
| 126899601 | 12689960 | 8 | C | ONDANSETRON ACCORD 2 mg/ml | ONDANSETRON | 1 | Intravenous drip | CHOEP 21 PROTOCOL, DAY 1, DAY 2 AND DAY 3 | 0 | 8 | MG | SOLUTION FOR INJECTION | |||||||
| 126899601 | 12689960 | 9 | C | GRANOCYTE | LENOGRASTIM | 1 | CHOEP 21 PROTOCOL, DAY 6 TO DAY 12 | 0 | |||||||||||
| 126899601 | 12689960 | 10 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 1000 MILLIGRAM DAILY; | 0 | 500 | MG | BID | |||||||
| 126899601 | 12689960 | 11 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 3.5714 MILLIGRAM DAILY; | 0 | 25 | MG | /wk | |||||||
| 126899601 | 12689960 | 12 | C | LEDERFOLINE | LEUCOVORIN CALCIUM | 1 | Oral | 3.5714 MILLIGRAM DAILY; | 0 | 25 | MG | /wk | |||||||
| 126899601 | 12689960 | 13 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | 200 MILLIGRAM DAILY; | 0 | 100 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126899601 | 12689960 | 10 | Prophylaxis |
| 126899601 | 12689960 | 11 | Prophylaxis |
| 126899601 | 12689960 | 12 | Prophylaxis |
| 126899601 | 12689960 | 13 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126899601 | 12689960 | HO |
| 126899601 | 12689960 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126899601 | 12689960 | Acute kidney injury | |
| 126899601 | 12689960 | Febrile bone marrow aplasia | |
| 126899601 | 12689960 | 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 |
|---|---|---|---|---|---|---|
| 126899601 | 12689960 | 1 | 20160106 | 20160106 | 0 | |
| 126899601 | 12689960 | 2 | 20160107 | 20160108 | 0 | |
| 126899601 | 12689960 | 3 | 20160106 | 20160106 | 0 | |
| 126899601 | 12689960 | 4 | 20160106 | 20160106 | 0 | |
| 126899601 | 12689960 | 5 | 20160106 | 20160106 | 0 | |
| 126899601 | 12689960 | 6 | 20160106 | 20160108 | 0 | |
| 126899601 | 12689960 | 7 | 20160109 | 20160110 | 0 | |
| 126899601 | 12689960 | 8 | 20160106 | 20160108 | 0 | |
| 126899601 | 12689960 | 9 | 20160111 | 20160117 | 0 |