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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 934598411 | 9345984 | 11 | F | 20130602 | 20160705 | 20130613 | 20160712 | EXP | NL-ROCHE-1232241 | ROCHE | 62.76 | YR | F | Y | 104.00000 | KG | 20160712 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 934598411 | 9345984 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 800 | MG | SOLUTION FOR INFUSION | ||||||||
| 934598411 | 9345984 | 2 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | ONCE DAILY PER CYCLE. | 1104004 | 103705 | 1400 | MG | SOLUTION FOR INJECTION | ||||||
| 934598411 | 9345984 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | ONCE DAILY PER CYCLE. | 0 | 1600 | MG | ||||||||
| 934598411 | 9345984 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 1600 | MG | |||||||||
| 934598411 | 9345984 | 5 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | ONCE DAILY PER CYCLE. | 0 | 105 | MG | ||||||||
| 934598411 | 9345984 | 6 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 0 | 105 | MG | |||||||||
| 934598411 | 9345984 | 7 | SS | VINCRISTIN | VINCRISTINE | 1 | Intravenous (not otherwise specified) | ONCE DAILY PER CYCLE. | 0 | 1 | MG | ||||||||
| 934598411 | 9345984 | 8 | SS | VINCRISTIN | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 0 | 1.4 | MG/M**2 | |||||||||
| 934598411 | 9345984 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 934598411 | 9345984 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | DATE OF LAST DOSE PRIOR TO THE SAE 28/MAY/2013 | 0 | ||||||||||
| 934598411 | 9345984 | 11 | C | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | |||||||||
| 934598411 | 9345984 | 12 | C | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | |||||||||
| 934598411 | 9345984 | 13 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 934598411 | 9345984 | 14 | C | ORAMORPH | MORPHINE SULFATE | 1 | Oral | 0 | QD | ||||||||||
| 934598411 | 9345984 | 15 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 0 | 300 | MG | QD | ||||||||
| 934598411 | 9345984 | 16 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 934598411 | 9345984 | 17 | C | Granisetron | GRANISETRON | 1 | Oral | 0 | 2 | MG | |||||||||
| 934598411 | 9345984 | 18 | C | LIDOCAINE. | LIDOCAINE | 1 | Oral | 0 | QD | ||||||||||
| 934598411 | 9345984 | 19 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 934598411 | 9345984 | 20 | C | MOVICOLON | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 1DD1 SACHET | 0 | QD | |||||||||
| 934598411 | 9345984 | 21 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 0 | 200 | MG | QD | ||||||||
| 934598411 | 9345984 | 22 | C | CLEMASTIN | CLEMASTINE | 1 | Intravenous (not otherwise specified) | 0 | 2 | MG | |||||||||
| 934598411 | 9345984 | 23 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | 480 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 934598411 | 9345984 | 1 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 2 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 3 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 5 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 7 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 9 | Diffuse large B-cell lymphoma |
| 934598411 | 9345984 | 15 | Prophylaxis |
| 934598411 | 9345984 | 17 | Prophylaxis |
| 934598411 | 9345984 | 22 | Prophylaxis |
| 934598411 | 9345984 | 23 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 934598411 | 9345984 | DE |
| 934598411 | 9345984 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 934598411 | 9345984 | Febrile neutropenia | |
| 934598411 | 9345984 | Hepatic enzyme increased | |
| 934598411 | 9345984 | Hepatic failure | |
| 934598411 | 9345984 | Herpes simplex hepatitis |
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 |
|---|---|---|---|---|---|---|
| 934598411 | 9345984 | 1 | 20130514 | 0 | ||
| 934598411 | 9345984 | 2 | 20130528 | 0 | ||
| 934598411 | 9345984 | 3 | 20130528 | 0 | ||
| 934598411 | 9345984 | 4 | 20130514 | 0 | ||
| 934598411 | 9345984 | 5 | 20130528 | 0 | ||
| 934598411 | 9345984 | 6 | 20130514 | 0 | ||
| 934598411 | 9345984 | 7 | 20130528 | 0 | ||
| 934598411 | 9345984 | 8 | 20130514 | 0 | ||
| 934598411 | 9345984 | 9 | 20130514 | 0 | ||
| 934598411 | 9345984 | 10 | 20130528 | 0 | ||
| 934598411 | 9345984 | 11 | 20130515 | 20130515 | 0 | |
| 934598411 | 9345984 | 12 | 20130529 | 20130529 | 0 | |
| 934598411 | 9345984 | 13 | 20130508 | 0 | ||
| 934598411 | 9345984 | 14 | 20130511 | 20130604 | 0 | |
| 934598411 | 9345984 | 15 | 20130508 | 20130602 | 0 | |
| 934598411 | 9345984 | 16 | 20130514 | 0 | ||
| 934598411 | 9345984 | 17 | 20130514 | 0 | ||
| 934598411 | 9345984 | 18 | 20130530 | 0 | ||
| 934598411 | 9345984 | 19 | 20130514 | 0 | ||
| 934598411 | 9345984 | 20 | 20130514 | 20130604 | 0 | |
| 934598411 | 9345984 | 21 | 20130527 | 20130602 | 0 | |
| 934598411 | 9345984 | 22 | 20130514 | 0 | ||
| 934598411 | 9345984 | 23 | 20130414 | 0 |