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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127452841 | 12745284 | 1 | I | 20160829 | 0 | 20160914 | 20160914 | DIR | FDA-CTU | 1.83 | YR | M | N | 26.40000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127452841 | 12745284 | 1 | PS | CYTARABINE. | CYTARABINE | 1 | 0 | ||||||||||||
| 127452841 | 12745284 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | 15 | MG | ||||||||||
| 127452841 | 12745284 | 4 | SS | ONCASPAR | PEGASPARGASE | 1 | 2400 UNIT | 0 | |||||||||||
| 127452841 | 12745284 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | 0 | 1281 | MG | ||||||||||
| 127452841 | 12745284 | 8 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | 0 | 4.5 | MG |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127452841 | 12745284 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127452841 | 12745284 | Anaemia | |
| 127452841 | 12745284 | Blood urine present | |
| 127452841 | 12745284 | Depressed level of consciousness | |
| 127452841 | 12745284 | Haemolytic anaemia | |
| 127452841 | 12745284 | Hepatomegaly | |
| 127452841 | 12745284 | Hyperbilirubinaemia | |
| 127452841 | 12745284 | Hypotension | |
| 127452841 | 12745284 | Hypoxia | |
| 127452841 | 12745284 | Posterior reversible encephalopathy syndrome | |
| 127452841 | 12745284 | Pyrexia | |
| 127452841 | 12745284 | Red blood cell spherocytes present | |
| 127452841 | 12745284 | Transaminases 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 |
|---|---|---|---|---|---|---|
| 127452841 | 12745284 | 1 | 20160813 | 0 | ||
| 127452841 | 12745284 | 2 | 20160822 | 0 | ||
| 127452841 | 12745284 | 4 | 20160817 | 0 | ||
| 127452841 | 12745284 | 6 | 20160828 | 0 | ||
| 127452841 | 12745284 | 8 | 20160822 | 0 |