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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321631 | 12532163 | 1 | I | 20120416 | 20120418 | 20160706 | 20160706 | EXP | PHHO2012ES020334 | NOVARTIS | 40.79 | YR | F | Y | 43.50000 | KG | 20160706 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321631 | 12532163 | 1 | PS | OFATUMUMAB | OFATUMUMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, CYCLIC | 125326 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 125321631 | 12532163 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 250 MG/M2, | 0 | 250 | MG/M**2 | ||||||||
| 125321631 | 12532163 | 3 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 25 MG/M2, | 0 | 25 | MG/M**2 | ||||||||
| 125321631 | 12532163 | 4 | C | PIPERACILINA | 2 | Intravenous (not otherwise specified) | 4 G, TID | U | 0 | 4 | G | TID | |||||||
| 125321631 | 12532163 | 5 | C | NEUPOGEN | FILGRASTIM | 1 | Subcutaneous | 300 UG, ONCE/SINGLE | U | 0 | 300 | UG | 1X | ||||||
| 125321631 | 12532163 | 6 | C | TAZOBACTAM | TAZOBACTAM | 1 | Intravenous (not otherwise specified) | 500 MG, TID | U | 0 | 500 | MG | TID | ||||||
| 125321631 | 12532163 | 7 | C | TAZOBACTAM | TAZOBACTAM | 1 | U | 0 | |||||||||||
| 125321631 | 12532163 | 8 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | U | 0 | 500 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125321631 | 12532163 | 1 | Chronic lymphocytic leukaemia |
| 125321631 | 12532163 | 2 | Chronic lymphocytic leukaemia |
| 125321631 | 12532163 | 3 | Chronic lymphocytic leukaemia |
| 125321631 | 12532163 | 4 | Infection prophylaxis |
| 125321631 | 12532163 | 5 | Febrile neutropenia |
| 125321631 | 12532163 | 6 | Infection prophylaxis |
| 125321631 | 12532163 | 7 | Infection prophylaxis |
| 125321631 | 12532163 | 8 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125321631 | 12532163 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125321631 | 12532163 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 125321631 | 12532163 | 1 | 20111121 | 20120327 | 0 | |
| 125321631 | 12532163 | 2 | 20111121 | 20120327 | 0 | |
| 125321631 | 12532163 | 3 | 20111121 | 20120327 | 0 | |
| 125321631 | 12532163 | 4 | 20120416 | 20120421 | 0 | |
| 125321631 | 12532163 | 5 | 20120416 | 20120416 | 0 | |
| 125321631 | 12532163 | 6 | 20120416 | 20120421 | 0 | |
| 125321631 | 12532163 | 8 | 20120422 | 20120426 | 0 |