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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127880571 | 12788057 | 1 | I | 20160902 | 0 | 20160928 | 20160928 | DIR | FDA-CTU | 4.17 | YR | M | N | 14.90000 | KG | 20160922 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127880571 | 12788057 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 0 | 116 | MG | ||||||||||
| 127880571 | 12788057 | 2 | SS | ONCASPAR | PEGASPARGASE | 1 | 0 | 1625 | IU | ||||||||||
| 127880571 | 12788057 | 3 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | 0 | 4 | MG | ||||||||||
| 127880571 | 12788057 | 4 | SS | CYTARABINE. | CYTARABINE | 1 | 0 | 70 | MG | ||||||||||
| 127880571 | 12788057 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | 0 | 24 | MG |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127880571 | 12788057 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127880571 | 12788057 | Acute kidney injury | |
| 127880571 | 12788057 | Blood creatinine increased | |
| 127880571 | 12788057 | Blood urea increased | |
| 127880571 | 12788057 | Electrocardiogram T wave abnormal | |
| 127880571 | 12788057 | Haemodialysis | |
| 127880571 | 12788057 | Hyperkalaemia | |
| 127880571 | 12788057 | Urate nephropathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127880571 | 12788057 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127880571 | 12788057 | 1 | 20160902 | 0 | ||
| 127880571 | 12788057 | 2 | 20160808 | 0 | ||
| 127880571 | 12788057 | 3 | 20160826 | 0 | ||
| 127880571 | 12788057 | 4 | 20160804 | 0 | ||
| 127880571 | 12788057 | 5 | 20160902 | 0 |