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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98302698 | 9830269 | 8 | F | 20140108 | 20160620 | 20140120 | 20160704 | EXP | IT-ROCHE-1331939 | ROCHE | 66.87 | YR | F | Y | 55.00000 | KG | 20160704 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98302698 | 9830269 | 1 | PS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE WAS ON 10/DEC/2013.?VOLUME OF LAST GA101 TAKEN WAS 250ML AND DOSE CONCENTRATI | Y | H0012 | 104405 | SOLUTION FOR INFUSION | Q3W | ||||||
| 98302698 | 9830269 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | DOSE OF LAST CYCLOPHOSPHAMIDE TAKEN 1155MG.?LAST DOSE PRIOR TO SAE WAS ON 11/DEC/2013 | Y | 0 | Q3W | ||||||||
| 98302698 | 9830269 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | DOSE OF LAST DOXORUBICIN TAKEN WAS 77MG.?LAST DOSE PRIOR TO SAE WAS ON 11/DEC/2013 | Y | 0 | Q3W | ||||||||
| 98302698 | 9830269 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous bolus | DOSE OF LAST VINCRISTINE TAKEN 2MG.?LAST DOSE PRIOR TO SAE WAS ON 11/DEC/2013 | Y | 0 | Q3W | ||||||||
| 98302698 | 9830269 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | DOSE OF LAST PREDNISONE WAS 12.5MG.?LAST DOSE PRIOR TO SAE WAS ON 21/DEC/2013 | Y | 0 | Q3W | ||||||||
| 98302698 | 9830269 | 6 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 98302698 | 9830269 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 8 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 98302698 | 9830269 | 9 | C | DELTACORTENE | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 10 | C | LEVOFLOXACINA | LEVOFLOXACIN | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 12 | C | TRIMETON (ITALY) | 2 | Unknown | 0 | ||||||||||||
| 98302698 | 9830269 | 13 | C | URBASON | METHYLPREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 14 | C | ITRACONAZOL | ITRACONAZOLE | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 15 | C | DIFLUCAN | FLUCONAZOLE | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 16 | C | ZOVIRAX | ACYCLOVIR | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 17 | C | CEFIXORAL | CEFIXIME | 1 | Unknown | 0 | |||||||||||
| 98302698 | 9830269 | 18 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98302698 | 9830269 | 1 | Diffuse large B-cell lymphoma |
| 98302698 | 9830269 | 2 | Diffuse large B-cell lymphoma |
| 98302698 | 9830269 | 3 | Diffuse large B-cell lymphoma |
| 98302698 | 9830269 | 4 | Diffuse large B-cell lymphoma |
| 98302698 | 9830269 | 5 | Diffuse large B-cell lymphoma |
| 98302698 | 9830269 | 6 | Prophylaxis |
| 98302698 | 9830269 | 7 | Antibiotic therapy |
| 98302698 | 9830269 | 8 | Renal hypoplasia |
| 98302698 | 9830269 | 10 | Prophylaxis |
| 98302698 | 9830269 | 11 | Premedication |
| 98302698 | 9830269 | 12 | Premedication |
| 98302698 | 9830269 | 13 | Premedication |
| 98302698 | 9830269 | 14 | Prophylaxis |
| 98302698 | 9830269 | 15 | Candida infection |
| 98302698 | 9830269 | 16 | Oral herpes |
| 98302698 | 9830269 | 17 | Cough |
| 98302698 | 9830269 | 18 | Neuropathy peripheral |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98302698 | 9830269 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98302698 | 9830269 | Pneumonia | |
| 98302698 | 9830269 | Pulmonary embolism |
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 |
|---|---|---|---|---|---|---|
| 98302698 | 9830269 | 1 | 20131029 | 0 | ||
| 98302698 | 9830269 | 2 | 20131030 | 0 | ||
| 98302698 | 9830269 | 3 | 20131030 | 0 | ||
| 98302698 | 9830269 | 4 | 20131030 | 0 | ||
| 98302698 | 9830269 | 5 | 20131030 | 0 | ||
| 98302698 | 9830269 | 7 | 20131119 | 20141104 | 0 | |
| 98302698 | 9830269 | 9 | 20131216 | 20131221 | 0 | |
| 98302698 | 9830269 | 10 | 20131215 | 20131224 | 0 | |
| 98302698 | 9830269 | 11 | 20131210 | 20131210 | 0 | |
| 98302698 | 9830269 | 12 | 20131210 | 20131210 | 0 | |
| 98302698 | 9830269 | 13 | 20131210 | 20131210 | 0 | |
| 98302698 | 9830269 | 14 | 20131215 | 20131224 | 0 | |
| 98302698 | 9830269 | 15 | 20131231 | 20140519 | 0 | |
| 98302698 | 9830269 | 16 | 20131231 | 20141104 | 0 | |
| 98302698 | 9830269 | 17 | 20131231 | 20140108 | 0 | |
| 98302698 | 9830269 | 18 | 20150527 | 0 |