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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98493788 | 9849378 | 8 | F | 20120526 | 20160920 | 20140128 | 20160920 | EXP | TH-ROCHE-1080464 | ROCHE | 56.92 | YR | F | Y | 67.65000 | KG | 20160920 | MD | TH | TH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98493788 | 9849378 | 1 | PS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | VOLUME AND CONCENTRATION OF LAST DOSE TAKEN 250 ML AND 4 MG/ML RESPECTIVELY, DATE OF LAST DOSE PRIOR | PDH0000143 | 125486 | SOLUTION FOR INFUSION | Q3W | |||||||
| 98493788 | 9849378 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | DOSE LAST TAKEN 1280 MG, DATE OF LAST DOSE PRIOR TO EVENT: 08/JUN/2012?LAST DOSE PRIOR TO FEBRILE NE | 0 | Q3W | |||||||||
| 98493788 | 9849378 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE TAKEN 85 MG, DATE OF LAST DOSE PRIOR TO EVENT: 08/JUN/2012?LAST DOSE PRIOR TO FEBRILE NEUT | 0 | Q3W | |||||||||
| 98493788 | 9849378 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | LAST DOSE TAKEN 2.0 MG, DATE OF LAST DOSE PRIOR TO EVENT: 08/JUN/2012, INTRAVENOUS PUSH?LAST DOSE PR | 0 | Q3W | |||||||||
| 98493788 | 9849378 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | LAST DOSE TAKEN 100 MG, DATE OF LAST DOSE PRIOR TO EVENT: 08/JUN/2012?LAST DOSE PRIOR TO FEBRILE NEU | 0 | Q3W | |||||||||
| 98493788 | 9849378 | 6 | C | WARFARIN | WARFARIN | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 7 | C | ENOXAPARIN | ENOXAPARIN | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 8 | C | GLIPIZIDE. | GLIPIZIDE | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 9 | C | ORFARIN | WARFARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 10 | C | BENADRYL (THAILAND) | 2 | Unknown | 0 | ||||||||||||
| 98493788 | 9849378 | 11 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 98493788 | 9849378 | 13 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | TABLET | ||||||||||
| 98493788 | 9849378 | 14 | C | ONDANSETRON | ONDANSETRON | 1 | 0 | ||||||||||||
| 98493788 | 9849378 | 15 | C | ONDANSETRON | ONDANSETRON | 1 | 0 | ||||||||||||
| 98493788 | 9849378 | 16 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98493788 | 9849378 | 1 | Diffuse large B-cell lymphoma |
| 98493788 | 9849378 | 2 | Diffuse large B-cell lymphoma |
| 98493788 | 9849378 | 3 | Diffuse large B-cell lymphoma |
| 98493788 | 9849378 | 4 | Diffuse large B-cell lymphoma |
| 98493788 | 9849378 | 5 | Diffuse large B-cell lymphoma |
| 98493788 | 9849378 | 6 | Deep vein thrombosis |
| 98493788 | 9849378 | 7 | Deep vein thrombosis |
| 98493788 | 9849378 | 8 | Diabetes mellitus |
| 98493788 | 9849378 | 9 | Thrombosis prophylaxis |
| 98493788 | 9849378 | 10 | Premedication |
| 98493788 | 9849378 | 11 | Premedication |
| 98493788 | 9849378 | 12 | Premedication |
| 98493788 | 9849378 | 13 | Premedication |
| 98493788 | 9849378 | 14 | Nausea |
| 98493788 | 9849378 | 15 | Vomiting |
| 98493788 | 9849378 | 16 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98493788 | 9849378 | LT |
| 98493788 | 9849378 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98493788 | 9849378 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 98493788 | 9849378 | 1 | 20120127 | 0 | ||
| 98493788 | 9849378 | 2 | 20120127 | 0 | ||
| 98493788 | 9849378 | 3 | 20120127 | 0 | ||
| 98493788 | 9849378 | 4 | 20120127 | 0 | ||
| 98493788 | 9849378 | 5 | 20120127 | 0 | ||
| 98493788 | 9849378 | 6 | 20120217 | 20120823 | 0 | |
| 98493788 | 9849378 | 7 | 20120601 | 20120607 | 0 | |
| 98493788 | 9849378 | 8 | 20120427 | 0 | ||
| 98493788 | 9849378 | 9 | 20120617 | 20120625 | 0 | |
| 98493788 | 9849378 | 10 | 20120127 | 20120629 | 0 | |
| 98493788 | 9849378 | 11 | 20120127 | 20120629 | 0 | |
| 98493788 | 9849378 | 12 | 20120127 | 20120629 | 0 | |
| 98493788 | 9849378 | 13 | 20120127 | 20120629 | 0 | |
| 98493788 | 9849378 | 16 | 20120709 | 0 |