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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127755151 | 12775515 | 1 | I | 20160907 | 0 | 20160920 | 20160920 | DIR | FDA-CTU | 14.19 | YR | M | N | 61.30000 | KG | 20160919 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127755151 | 12775515 | 1 | PS | CYTARABINE. | CYTARABINE | 1 | D | D | 0 | 70 | MG | ||||||||
| 127755151 | 12775515 | 2 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | 0 | 104.4 | MG | ||||||||||
| 127755151 | 12775515 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | 30 | MG | ||||||||||
| 127755151 | 12775515 | 4 | SS | ONCASPAR | PEGASPARGASE | 1 | 4162.5 UNIT | 0 | 4162.5 | DF | |||||||||
| 127755151 | 12775515 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | 0 | 2800 | MG | ||||||||||
| 127755151 | 12775515 | 6 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | 0 | 6 | MG |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127755151 | 12775515 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127755151 | 12775515 | Cytomegalovirus infection | |
| 127755151 | 12775515 | Hepatosplenomegaly | |
| 127755151 | 12775515 | Hyperbilirubinaemia | |
| 127755151 | 12775515 | Liver function test increased | |
| 127755151 | 12775515 | Pancytopenia | |
| 127755151 | 12775515 | Serum ferritin increased |
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 |
|---|---|---|---|---|---|---|
| 127755151 | 12775515 | 1 | 20160811 | 0 | ||
| 127755151 | 12775515 | 2 | 20160902 | 0 | ||
| 127755151 | 12775515 | 3 | 20160819 | 0 | ||
| 127755151 | 12775515 | 4 | 20160815 | 0 | ||
| 127755151 | 12775515 | 5 | 20160908 | 0 | ||
| 127755151 | 12775515 | 6 | 20160902 | 0 |