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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123117694 | 12311769 | 4 | F | 20130427 | 20160816 | 20160427 | 20160830 | EXP | JP-SA-2016SA080689 | AVENTIS | 65.00 | YR | E | F | Y | 69.90000 | KG | 20160830 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123117694 | 12311769 | 1 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 5 DOSES IN 4 WEEKS | UNKNOWN | 20038 | 30 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 123117694 | 12311769 | 2 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 5 DOSES IN 4 WEEKS | UNKNOWN | 20038 | 30 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 123117694 | 12311769 | 3 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 3 DOSES IN 4 WEEKS | UNKNOWN | 20038 | 30 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 123117694 | 12311769 | 4 | C | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 600 | MG | |||||||||
| 123117694 | 12311769 | 5 | C | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 400 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123117694 | 12311769 | 1 | Chronic lymphocytic leukaemia |
| 123117694 | 12311769 | 2 | Chronic lymphocytic leukaemia |
| 123117694 | 12311769 | 3 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123117694 | 12311769 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123117694 | 12311769 | Ascites | |
| 123117694 | 12311769 | Jaundice | |
| 123117694 | 12311769 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 123117694 | 12311769 | 1 | 20130228 | 20130401 | 0 | |
| 123117694 | 12311769 | 2 | 20130402 | 20130502 | 0 | |
| 123117694 | 12311769 | 3 | 20130503 | 20130602 | 0 | |
| 123117694 | 12311769 | 4 | 20130502 | 20130602 | 0 | |
| 123117694 | 12311769 | 5 | 20130503 | 20130602 | 0 |