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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117427722 | 11742772 | 2 | F | 20151103 | 20160817 | 20151116 | 20160823 | EXP | PHHO2015US019016 | SANDOZ | 9.34 | YR | M | Y | 28.40000 | KG | 20160823 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117427722 | 11742772 | 1 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, QD X 4 | 22137 | 30 | MG/M**2 | QD | |||||||
| 117427722 | 11742772 | 2 | SS | NO TREATMENT RECEIVED | UNSPECIFIED INGREDIENT | 1 | Unknown | NO TREATMENT | 0 | ||||||||||
| 117427722 | 11742772 | 3 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 500 MG/M2, QD X 2 | 0 | 500 | MG/M**2 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117427722 | 11742772 | 1 | Acute lymphocytic leukaemia |
| 117427722 | 11742772 | 2 | Acute lymphocytic leukaemia |
| 117427722 | 11742772 | 3 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117427722 | 11742772 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117427722 | 11742772 | Flushing | |
| 117427722 | 11742772 | Hypotension | |
| 117427722 | 11742772 | 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 |
|---|---|---|---|---|---|---|
| 117427722 | 11742772 | 1 | 20151103 | 20151103 | 0 | |
| 117427722 | 11742772 | 3 | 20151103 | 20151103 | 0 |