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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126750941 | 12675094 | 1 | I | 20160220 | 20160818 | 20160823 | 20160823 | EXP | FR-ROCHE-1817021 | ROCHE | 59.00 | YR | M | Y | 72.00000 | KG | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126750941 | 12675094 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous drip | (DAY 1) | U | 103705 | 740 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 2 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | 0 | ||||||||||
| 126750941 | 12675094 | 3 | SS | DOXORUBICINE TEVA | DOXORUBICIN | 1 | Intravenous drip | 200 MG/100 ML (DAY 1) | U | 0 | 150 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 4 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | (DAY 1) | U | 0 | 2350 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 5 | SS | BLEOMYCINE BELLON | BLEOMYCIN SULFATE | 1 | Intravenous drip | (DAY 1 AND DAY 5) | U | 0 | 10 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 6 | SS | UROMITEXAN | MESNA | 1 | Oral | 1598 MG TWICE (DAY 1) | U | 0 | 3196 | MG | TABLET | ||||||
| 126750941 | 12675094 | 7 | SS | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | 5 MG/1 ML?5 MG TWICE BY SLOW INTRAVENOUS ROUTE (DAY 1), 5 MG VIA SLOW INTRAVENOUS ROUTE (DAY 5) | U | 0 | 5 | MG | |||||||
| 126750941 | 12675094 | 8 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous drip | (DAY 1 AND DAY 5) | U | 0 | 117.6 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 9 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous drip | (DAY 1) | U | 0 | 500 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 10 | SS | METHOTREXATE BIODIM | METHOTREXATE | 1 | Intradiscal (intraspinal) | (DAY 1) | U | 0 | 15 | MG | |||||||
| 126750941 | 12675094 | 11 | SS | ONDANSETRON A | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2 MG/ML?(DAY 1) | U | 0 | 8 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 12 | SS | ELDISINE | VINDESINE SULFATE | 1 | Intravenous drip | (DAY 1 AND DAY 5) | U | 0 | 3.9 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 13 | SS | MESNA. | MESNA | 1 | Intravenous drip | (DAY 1) | U | 0 | 784 | MG | SOLUTION FOR INFUSION | ||||||
| 126750941 | 12675094 | 14 | SS | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 126750941 | 12675094 | 15 | SS | LEDERFOLINE | LEUCOVORIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 126750941 | 12675094 | 16 | SS | ZYLORIC | ALLOPURINOL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126750941 | 12675094 | 1 | Product used for unknown indication |
| 126750941 | 12675094 | 2 | Infection prophylaxis |
| 126750941 | 12675094 | 3 | Product used for unknown indication |
| 126750941 | 12675094 | 4 | Product used for unknown indication |
| 126750941 | 12675094 | 5 | Product used for unknown indication |
| 126750941 | 12675094 | 6 | Product used for unknown indication |
| 126750941 | 12675094 | 7 | Product used for unknown indication |
| 126750941 | 12675094 | 8 | Product used for unknown indication |
| 126750941 | 12675094 | 9 | Product used for unknown indication |
| 126750941 | 12675094 | 10 | Product used for unknown indication |
| 126750941 | 12675094 | 11 | Product used for unknown indication |
| 126750941 | 12675094 | 12 | Product used for unknown indication |
| 126750941 | 12675094 | 13 | Product used for unknown indication |
| 126750941 | 12675094 | 14 | Infection prophylaxis |
| 126750941 | 12675094 | 15 | Infection prophylaxis |
| 126750941 | 12675094 | 16 | Tumour lysis syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126750941 | 12675094 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126750941 | 12675094 | Febrile neutropenia | |
| 126750941 | 12675094 | Stomatitis | |
| 126750941 | 12675094 | Weight 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 |
|---|---|---|---|---|---|---|
| 126750941 | 12675094 | 1 | 20160211 | 0 | ||
| 126750941 | 12675094 | 3 | 20160211 | 0 | ||
| 126750941 | 12675094 | 4 | 20160211 | 0 | ||
| 126750941 | 12675094 | 5 | 20160211 | 0 | ||
| 126750941 | 12675094 | 6 | 20160211 | 0 | ||
| 126750941 | 12675094 | 7 | 20160211 | 0 | ||
| 126750941 | 12675094 | 8 | 20160211 | 0 | ||
| 126750941 | 12675094 | 9 | 20160211 | 0 | ||
| 126750941 | 12675094 | 10 | 20160211 | 0 | ||
| 126750941 | 12675094 | 11 | 20160211 | 0 | ||
| 126750941 | 12675094 | 12 | 20160211 | 0 | ||
| 126750941 | 12675094 | 13 | 20160211 | 0 |