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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112201 | 12711220 | 1 | I | 20160219 | 20160819 | 20160902 | 20160902 | EXP | RE20160791 | FR-ACCORD-043597 | ACCORD | 59.00 | YR | M | Y | 72.00000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112201 | 12711220 | 1 | PS | Ondansetron Accord | ONDANSETRON | 1 | Intravenous drip | STRENGTH: 2 MG/ML | U | 206846 | 16 | MG | SOLUTION FOR INJECTION | ||||||
| 127112201 | 12711220 | 2 | SS | DOXORUBICINE TEVA | DOXORUBICIN | 1 | Intravenous drip | STRENGTH: 200 MG/100 ML | U | 0 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 127112201 | 12711220 | 3 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | U | 0 | 2350 | MG | INFUSION | |||||||
| 127112201 | 12711220 | 4 | SS | BLEOMYCINE BELLON | BLEOMYCIN SULFATE | 1 | Intravenous drip | STRENGTH: 15 MG | U | 0 | 10 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 127112201 | 12711220 | 5 | SS | UROMITEXAN | MESNA | 1 | Oral | U | 0 | 3196 | MG | BID | |||||||
| 127112201 | 12711220 | 6 | SS | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | STRENGHT: 5 MG/1 ML | U | 0 | 5 | MG | SOLUTION FOR INJECTION | BID | |||||
| 127112201 | 12711220 | 7 | SS | METHYLPREDNISOLONE MYLAN | METHYLPREDNISOLONE | 1 | Intravenous drip | U | 0 | 117.6 | MG | INFUSION | |||||||
| 127112201 | 12711220 | 8 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous drip | U | 0 | 740 | MG | INFUSION | |||||||
| 127112201 | 12711220 | 9 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous drip | U | 0 | 500 | MG | INFUSION | |||||||
| 127112201 | 12711220 | 10 | SS | METHOTREXATE BIODIM | METHOTREXATE | 1 | Intrathecal | U | 0 | 15 | MG | ||||||||
| 127112201 | 12711220 | 11 | SS | ELDISINE | VINDESINE SULFATE | 1 | Intravenous drip | U | 0 | 3.9 | MG | INFUSION | |||||||
| 127112201 | 12711220 | 12 | SS | MESNA EG | MESNA | 1 | Intravenous drip | STRENGTH: 100 MG/ML,??DOSAGE FORM: INJECTABLE SOLUTION FOR INFUSION | U | 0 | 784 | MG | SOLUTION FOR INFUSION | ||||||
| 127112201 | 12711220 | 13 | SS | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127112201 | 12711220 | 14 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | U | 0 | TABLET | ||||||||||
| 127112201 | 12711220 | 15 | SS | LEDERFOLINE | LEUCOVORIN CALCIUM | 1 | U | 0 | |||||||||||
| 127112201 | 12711220 | 16 | SS | ZYLORIC | ALLOPURINOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127112201 | 12711220 | 1 | Product used for unknown indication |
| 127112201 | 12711220 | 2 | Product used for unknown indication |
| 127112201 | 12711220 | 3 | Product used for unknown indication |
| 127112201 | 12711220 | 4 | Product used for unknown indication |
| 127112201 | 12711220 | 5 | Product used for unknown indication |
| 127112201 | 12711220 | 6 | Product used for unknown indication |
| 127112201 | 12711220 | 7 | Product used for unknown indication |
| 127112201 | 12711220 | 8 | Product used for unknown indication |
| 127112201 | 12711220 | 9 | Product used for unknown indication |
| 127112201 | 12711220 | 10 | Product used for unknown indication |
| 127112201 | 12711220 | 11 | Product used for unknown indication |
| 127112201 | 12711220 | 12 | Product used for unknown indication |
| 127112201 | 12711220 | 13 | Prophylaxis |
| 127112201 | 12711220 | 14 | Prophylaxis |
| 127112201 | 12711220 | 15 | Prophylaxis |
| 127112201 | 12711220 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127112201 | 12711220 | LT |
| 127112201 | 12711220 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127112201 | 12711220 | Febrile neutropenia | |
| 127112201 | 12711220 | Odynophagia | |
| 127112201 | 12711220 | Stomatitis | |
| 127112201 | 12711220 | 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 |
|---|---|---|---|---|---|---|
| 127112201 | 12711220 | 1 | 20160211 | 0 | ||
| 127112201 | 12711220 | 2 | 20160211 | 0 | ||
| 127112201 | 12711220 | 3 | 20160211 | 0 | ||
| 127112201 | 12711220 | 4 | 20160211 | 0 | ||
| 127112201 | 12711220 | 5 | 20160211 | 0 | ||
| 127112201 | 12711220 | 6 | 20160211 | 0 | ||
| 127112201 | 12711220 | 7 | 20160211 | 0 | ||
| 127112201 | 12711220 | 8 | 20160211 | 0 | ||
| 127112201 | 12711220 | 9 | 20160211 | 0 | ||
| 127112201 | 12711220 | 10 | 20160211 | 0 | ||
| 127112201 | 12711220 | 11 | 20160211 | 0 |