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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121941602 | 12194160 | 2 | F | 20160308 | 20160803 | 20160321 | 20160809 | EXP | FR-ROCHE-1728852 | ROCHE | 81.68 | YR | F | Y | 80.00000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121941602 | 12194160 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE 07/JAN/2016 | 103705 | 700 | MG | SOLUTION FOR INFUSION | |||||||
| 121941602 | 12194160 | 2 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | DATE OF LAST DOSE PRIOR TO SAE 17/FEB/2016 AND INTERRUPTED | Y | 103705 | 1400 | MG | SOLUTION FOR INJECTION | ||||||
| 121941602 | 12194160 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Unknown | DATE OF LAST DOSE PRIOR TO SAE 01/MAR/2016 AND INTERRUPTED | Y | 0 | 10 | MG | |||||||
| 121941602 | 12194160 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 5 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 6 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 7 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 10 | C | SOTALOL HYDROCHLORIDE. | SOTALOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 11 | C | ALTIZIDE + SPIRONOLACTONE | 2 | 0 | |||||||||||||
| 121941602 | 12194160 | 12 | C | FLUINDIONE | FLUINDIONE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 13 | C | SULFAMETHOXAZOLE/TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 14 | C | VALACICLOVIR HCL | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 15 | C | ACIDE FOLIQUE | FOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 17 | C | SODIUM ALGINATE | SODIUM ALGINATE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 18 | C | BICARBONATE DE SODIUM | SODIUM BICARBONATE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 19 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 20 | C | POLYSORBATE 80. | POLYSORBATE 80 | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 21 | C | BENZODODECINIUM BROMIDE. | BENZODODECINIUM BROMIDE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 22 | C | CLAFORAN (FRANCE) | 2 | 0 | |||||||||||||
| 121941602 | 12194160 | 23 | C | LEVOFLOXACIN HEMIHYDRATE | LEVOFLOXACIN | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 24 | C | SALBUTAMOL SULPHATE | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 25 | C | IPRATROPIUM BROMIDE MONOHYDRATE | IPRATROPIUM BROMIDE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 26 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | ||||||||||||
| 121941602 | 12194160 | 27 | C | Oseltamivir | OSELTAMIVIR | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 28 | C | CEFTRIAXONE SODIUM. | CEFTRIAXONE SODIUM | 1 | Unknown | 0 | |||||||||||
| 121941602 | 12194160 | 29 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121941602 | 12194160 | 1 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 2 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 3 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 4 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 5 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 6 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 8 | Diffuse large B-cell lymphoma |
| 121941602 | 12194160 | 10 | Hypertension |
| 121941602 | 12194160 | 11 | Hypertension |
| 121941602 | 12194160 | 12 | Atrial fibrillation |
| 121941602 | 12194160 | 13 | Infection prophylaxis |
| 121941602 | 12194160 | 14 | Infection prophylaxis |
| 121941602 | 12194160 | 15 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121941602 | 12194160 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121941602 | 12194160 | Influenza | |
| 121941602 | 12194160 | Lung infection |
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 |
|---|---|---|---|---|---|---|
| 121941602 | 12194160 | 1 | 20160107 | 20160107 | 0 | |
| 121941602 | 12194160 | 2 | 20160127 | 0 | ||
| 121941602 | 12194160 | 3 | 20160107 | 0 | ||
| 121941602 | 12194160 | 4 | 20160107 | 0 | ||
| 121941602 | 12194160 | 5 | 20160107 | 0 | ||
| 121941602 | 12194160 | 6 | 20151230 | 20160102 | 0 | |
| 121941602 | 12194160 | 7 | 20160107 | 0 | ||
| 121941602 | 12194160 | 8 | 20151230 | 20160102 | 0 | |
| 121941602 | 12194160 | 9 | 20160107 | 0 | ||
| 121941602 | 12194160 | 13 | 20151230 | 0 | ||
| 121941602 | 12194160 | 14 | 20151230 | 0 | ||
| 121941602 | 12194160 | 15 | 20151230 | 0 | ||
| 121941602 | 12194160 | 16 | 20151230 | 0 |