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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125778235 | 12577823 | 5 | F | 20160608 | 20160816 | 20160721 | 20160817 | EXP | DE-ROCHE-1782876 | ROCHE | 60.00 | YR | M | Y | 56.00000 | KG | 20160817 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125778235 | 12577823 | 1 | PS | Rituximab | RITUXIMAB | 1 | Subcutaneous | LAST DOSE PRIOR TO SAE ON 13/JUL/2016 | U | 103705 | 1400 | MG | SOLUTION FOR INJECTION | Q3W | |||||
| 125778235 | 12577823 | 2 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | U | 103705 | 1400 | MG | SOLUTION FOR INJECTION | |||||||
| 125778235 | 12577823 | 3 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | U | 0 | 6 | MG | ||||||||
| 125778235 | 12577823 | 4 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | U | 0 | 6 | MG | ||||||||
| 125778235 | 12577823 | 5 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | U | 0 | 6 | MG | ||||||||
| 125778235 | 12577823 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 1215 | MG | ||||||||
| 125778235 | 12577823 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 13/JUL/2016 | U | 0 | 750 | MG/M**2 | |||||||
| 125778235 | 12577823 | 8 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 13/JUL/2016 | U | 0 | 81 | MG | |||||||
| 125778235 | 12577823 | 9 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG/M**2 | ||||||||
| 125778235 | 12577823 | 10 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 13/JUL/2016 | U | 0 | 2 | MG | |||||||
| 125778235 | 12577823 | 11 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | U | 0 | 1 | MG/M**2 | ||||||||
| 125778235 | 12577823 | 12 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 100 | MG | QD | ||||||||
| 125778235 | 12577823 | 13 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | |||||||||||
| 125778235 | 12577823 | 14 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 100 | MG | |||||||||
| 125778235 | 12577823 | 15 | SS | COTRIM FORTE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | 860 | MG | |||||||||
| 125778235 | 12577823 | 16 | SS | COTRIM FORTE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | 960 | MG | |||||||||
| 125778235 | 12577823 | 17 | SS | ACIC | ACYCLOVIR | 1 | Oral | 0 | 800 | MG | |||||||||
| 125778235 | 12577823 | 18 | SS | ACIC | ACYCLOVIR | 1 | Oral | 0 | 400 | MG | |||||||||
| 125778235 | 12577823 | 19 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 0 | 3.5 | MG | |||||||||
| 125778235 | 12577823 | 20 | C | CYCLOSPORIN A | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 125778235 | 12577823 | 21 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0 | 1 | G | |||||||||
| 125778235 | 12577823 | 22 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 125778235 | 12577823 | 23 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | 150 | MG | |||||||||
| 125778235 | 12577823 | 24 | C | RAMIPRIL. | RAMIPRIL | 1 | 0 | ||||||||||||
| 125778235 | 12577823 | 25 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | 100 | MG | |||||||||
| 125778235 | 12577823 | 26 | C | OMEPRAZOL | OMEPRAZOLE | 1 | Unknown | 0 | 40 | MG | |||||||||
| 125778235 | 12577823 | 27 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 0 | 2 | G | |||||||||
| 125778235 | 12577823 | 28 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 0 | 300 | G | |||||||||
| 125778235 | 12577823 | 29 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 0 | 20 | MG | |||||||||
| 125778235 | 12577823 | 30 | C | CALCIUM ACETATE. | CALCIUM ACETATE | 1 | Unknown | 0 | 475 | MG | |||||||||
| 125778235 | 12577823 | 31 | C | VIGANTOLETTEN | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 125778235 | 12577823 | 32 | C | TACROLIMUS. | TACROLIMUS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125778235 | 12577823 | 1 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 3 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 6 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 8 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 10 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 12 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 15 | Post transplant lymphoproliferative disorder |
| 125778235 | 12577823 | 17 | Post transplant lymphoproliferative disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125778235 | 12577823 | LT |
| 125778235 | 12577823 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125778235 | 12577823 | Arthritis | |
| 125778235 | 12577823 | Cerebrovascular accident | |
| 125778235 | 12577823 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125778235 | 12577823 | 1 | 20160412 | 0 | ||
| 125778235 | 12577823 | 2 | 20160622 | 20160622 | 0 | |
| 125778235 | 12577823 | 3 | 20160604 | 20160604 | 0 | |
| 125778235 | 12577823 | 4 | 20160620 | 20160625 | 0 | |
| 125778235 | 12577823 | 5 | 20160716 | 20160716 | 0 | |
| 125778235 | 12577823 | 6 | 20160601 | 20160601 | 0 | |
| 125778235 | 12577823 | 7 | 20160622 | 20160622 | 0 | |
| 125778235 | 12577823 | 8 | 20160601 | 20160601 | 0 | |
| 125778235 | 12577823 | 9 | 20160622 | 20160622 | 0 | |
| 125778235 | 12577823 | 10 | 20160601 | 20160601 | 0 | |
| 125778235 | 12577823 | 11 | 20160622 | 20160622 | 0 | |
| 125778235 | 12577823 | 12 | 20160601 | 20160605 | 0 | |
| 125778235 | 12577823 | 14 | 20160622 | 20160626 | 0 | |
| 125778235 | 12577823 | 15 | 20160528 | 0 | ||
| 125778235 | 12577823 | 16 | 20160628 | 0 | ||
| 125778235 | 12577823 | 17 | 20160601 | 0 | ||
| 125778235 | 12577823 | 18 | 20160601 | 0 | ||
| 125778235 | 12577823 | 19 | 200403 | 0 | ||
| 125778235 | 12577823 | 21 | 200403 | 0 |