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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120764603 | 12076460 | 3 | F | 20160204 | 20160705 | 20160215 | 20160713 | EXP | FR-ROCHE-1709871 | ROCHE | 86.95 | YR | F | Y | 63.00000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120764603 | 12076460 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR SAE: 07/DEC/2015 | 103705 | 640 | MG | SOLUTION FOR INFUSION | |||||||
| 120764603 | 12076460 | 2 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | MOST RECENT DOSE PRIOE TO SAE: 19/JAN/2016 | Y | 103705 | 1400 | MG | SOLUTION FOR INJECTION | ||||||
| 120764603 | 12076460 | 3 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | Y | 103705 | 1400 | MG | SOLUTION FOR INJECTION | |||||||
| 120764603 | 12076460 | 4 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | MOST RECENT DOSE PRIOR SAE: 01/FEB/2016 | Y | 0 | 10 | MG | CAPSULE | ||||||
| 120764603 | 12076460 | 5 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | Y | 0 | 5 | MG | CAPSULE | |||||||
| 120764603 | 12076460 | 6 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 0 | |||||||||||
| 120764603 | 12076460 | 7 | C | DOXORUBICINE | DOXORUBICIN | 1 | Unknown | 0 | |||||||||||
| 120764603 | 12076460 | 8 | C | VINCRISTINE | VINCRISTINE | 1 | Unknown | PRE-PHASE TREATMENT | 0 | ||||||||||
| 120764603 | 12076460 | 9 | C | VINCRISTINE | VINCRISTINE | 1 | Unknown | 0 | |||||||||||
| 120764603 | 12076460 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | PRE-PHASE TREATMENT | 0 | ||||||||||
| 120764603 | 12076460 | 11 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120764603 | 12076460 | 1 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 2 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 4 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 6 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 7 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 8 | Diffuse large B-cell lymphoma |
| 120764603 | 12076460 | 10 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120764603 | 12076460 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120764603 | 12076460 | Hypokalaemia | |
| 120764603 | 12076460 | Phlebitis |
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 |
|---|---|---|---|---|---|---|
| 120764603 | 12076460 | 1 | 20151207 | 0 | ||
| 120764603 | 12076460 | 2 | 20151228 | 0 | ||
| 120764603 | 12076460 | 3 | 20160215 | 0 | ||
| 120764603 | 12076460 | 4 | 20151208 | 0 | ||
| 120764603 | 12076460 | 5 | 20160215 | 0 | ||
| 120764603 | 12076460 | 6 | 20151207 | 0 | ||
| 120764603 | 12076460 | 7 | 20151207 | 0 | ||
| 120764603 | 12076460 | 8 | 20151130 | 20151203 | 0 | |
| 120764603 | 12076460 | 9 | 20151207 | 0 | ||
| 120764603 | 12076460 | 10 | 20151130 | 20151203 | 0 | |
| 120764603 | 12076460 | 11 | 20151207 | 0 |