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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537241 | 12753724 | 1 | I | 20151230 | 20160905 | 20160916 | 20160916 | EXP | FR-BAXTER-2016BAX046224 | BAXTER | 72.87 | YR | F | Y | 66.00000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537241 | 12753724 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, THREE COURSES | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 127537241 | 12753724 | 2 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, FOURTH COURSE | 12142 | 1220 | MG | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||
| 127537241 | 12753724 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Subcutaneous | R-CHOP PROTOCOL, THREE COURSES | 0 | /cycle | |||||||||
| 127537241 | 12753724 | 4 | SS | MABTHERA | RITUXIMAB | 1 | Subcutaneous | R-CHOP PROTOCOL, FOURTH COURSE | 0 | 1400 | MG | /cycle | |||||||
| 127537241 | 12753724 | 5 | SS | Doxorubicine Teva | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, THREE COURSES | 0 | /cycle | |||||||||
| 127537241 | 12753724 | 6 | SS | Doxorubicine Teva | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, FOURTH COURSE | 0 | 81 | MG | /cycle | |||||||
| 127537241 | 12753724 | 7 | SS | Vincristine Hospira | VINCRISTINE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, THREE COURSES | 0 | /cycle | |||||||||
| 127537241 | 12753724 | 8 | SS | Vincristine Hospira | VINCRISTINE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, FOURTH COURSE | 0 | 2 | MG | /cycle | |||||||
| 127537241 | 12753724 | 9 | SS | Methylprednisolone Mylan | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, THREE COURSES | 0 | /cycle | |||||||||
| 127537241 | 12753724 | 10 | SS | Methylprednisolone Mylan | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | INFUSION, R-CHOP PROTOCOL, FOURTH COURSE | 0 | 80 | MG | /cycle | |||||||
| 127537241 | 12753724 | 11 | SS | Cortancyl | PREDNISONE | 1 | Oral | 0 | 100 | MG | |||||||||
| 127537241 | 12753724 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | U | 0 | 15 | MG | ||||||||
| 127537241 | 12753724 | 13 | SS | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | MG | ||||||||
| 127537241 | 12753724 | 14 | SS | paracetamol | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | INFUSION | U | 0 | 500 | MG | |||||||
| 127537241 | 12753724 | 15 | SS | Ondansetron Accord | ONDANSETRON | 1 | Intravenous (not otherwise specified) | INFUSION | U | 0 | 8 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127537241 | 12753724 | 1 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 3 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 5 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 7 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 9 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 11 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 12 | Diffuse large B-cell lymphoma |
| 127537241 | 12753724 | 13 | Product used for unknown indication |
| 127537241 | 12753724 | 14 | Product used for unknown indication |
| 127537241 | 12753724 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127537241 | 12753724 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127537241 | 12753724 | Acute prerenal failure | |
| 127537241 | 12753724 | Campylobacter gastroenteritis |
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 |
|---|---|---|---|---|---|---|
| 127537241 | 12753724 | 2 | 20151221 | 0 | ||
| 127537241 | 12753724 | 4 | 20151221 | 0 | ||
| 127537241 | 12753724 | 6 | 20151221 | 0 | ||
| 127537241 | 12753724 | 8 | 20151221 | 0 | ||
| 127537241 | 12753724 | 10 | 20151221 | 0 | ||
| 127537241 | 12753724 | 11 | 20151222 | 0 | ||
| 127537241 | 12753724 | 12 | 20151221 | 0 | ||
| 127537241 | 12753724 | 13 | 20151221 | 0 | ||
| 127537241 | 12753724 | 14 | 20151221 | 0 | ||
| 127537241 | 12753724 | 15 | 20151221 | 0 |