Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6253703 | 6954958 | F | 3 | 6253703-0 | 20090302 | 20090619 | 20090630 | EXP | 2009EN000047 | ENZON, INC. | 13 | YR | F | N | 80 | KG | 20090629 | MD | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6253703 | 1011826858 | PS | ONCASPAR | 1 | INTRAVENOUS | 4750 IU; X1; IV, 3750 IU; X1; IV | D | D | |||
| 6253703 | 1011871300 | SS | PREDNISONE TAB | 1 | ORAL | 3360 MG; BID; PO | D | D | |||
| 6253703 | 1011871301 | SS | DAUNORUBICIN HCL | 1 | INTRAVENOUS | 160 MG; QW; IV | D | D | |||
| 6253703 | 1011871361 | SS | METHOTREXATE | 1 | INTRATHECAL | 30 MG; INTH, 60 MG; INTH | D | D | |||
| 6253703 | 1011871413 | SS | CYTARABINE | 1 | INTRATHECAL | 70 MG; X1; INTH, 2080 MG; IV | D | D | |||
| 6253703 | 1011871429 | SS | VINCRISTINE | 1 | INTRAVENOUS | 7.9 MG; IV, 8 MG; IV | D | D | |||
| 6253703 | 1011871430 | SS | MERCAPTOPURINE | 1 | ORAL | 2825 MG; QD; PO | D | D | |||
| 6253703 | 1011871431 | SS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | 3420 MG; QM; IV | D | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6253703 | 1011826858 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871300 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871301 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871361 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871413 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871429 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871430 | ACUTE LYMPHOCYTIC LEUKAEMIA |
| 6253703 | 1011871431 | ACUTE LYMPHOCYTIC LEUKAEMIA |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6253703 | HO |
| 6253703 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6253703 | ABDOMINAL PAIN UPPER |
| 6253703 | ASTHENIA |
| 6253703 | BLOOD CULTURE POSITIVE |
| 6253703 | HYPERBILIRUBINAEMIA |
| 6253703 | HYPERCHOLESTEROLAEMIA |
| 6253703 | HYPERGLYCAEMIA |
| 6253703 | HYPERTRIGLYCERIDAEMIA |
| 6253703 | HYPOGLYCAEMIA |
| 6253703 | MUCOSAL INFLAMMATION |
| 6253703 | SEPSIS |
| 6253703 | STAPHYLOCOCCAL INFECTION |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6253703 | HP |
| 6253703 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6253703 | 1011826858 | 20090202 | 20090202 | ||
| 6253703 | 1011826858 | 20090429 | 20090429 | ||
| 6253703 | 1011871300 | 20090130 | |||
| 6253703 | 1011871301 | 20090130 | 20090220 | ||
| 6253703 | 1011871361 | 20090206 | 20090227 | ||
| 6253703 | 1011871361 | 20090401 | |||
| 6253703 | 1011871413 | 20090130 | 20090130 | ||
| 6253703 | 1011871413 | 20090425 | |||
| 6253703 | 1011871429 | 20090130 | 20090220 | ||
| 6253703 | 1011871429 | 20090509 | |||
| 6253703 | 1011871430 | 20090408 | |||
| 6253703 | 1011871431 | 20090415 |