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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127368301 | 12736830 | 1 | I | 20160531 | 20160904 | 20160913 | 20160913 | EXP | US-AMGEN-USACT2016119827 | AMGEN | 20.00 | YR | A | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127368301 | 12736830 | 1 | PS | blinatumomab | BLINATUMOMAB | 1 | Intravenous (not otherwise specified) | 15 MUG/M2, QD | U | 125557 | 15 | UG/M**2 | INVESTIGATIONAL DOSAGE FORM | QD | |||||
| 127368301 | 12736830 | 2 | SS | AMBISOME | AMPHOTERICIN B | 1 | Unknown | 0 | |||||||||||
| 127368301 | 12736830 | 3 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TO 15 MG, UNK | 0 | |||||||||||
| 127368301 | 12736830 | 4 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 8-15 MG, UNK | 0 | |||||||||||
| 127368301 | 12736830 | 5 | C | CYTARABINE. | CYTARABINE | 1 | 16-30 MG, UNK | 0 | |||||||||||
| 127368301 | 12736830 | 6 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 75 MG/M2, UNK | 0 | 75 | MG/M**2 | ||||||||
| 127368301 | 12736830 | 7 | C | VINCRISTINE | VINCRISTINE | 1 | Oral | 1.5 MG/M2, UNK | 0 | 1.5 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127368301 | 12736830 | 1 | Acute lymphocytic leukaemia |
| 127368301 | 12736830 | 2 | Product used for unknown indication |
| 127368301 | 12736830 | 3 | Acute lymphocytic leukaemia |
| 127368301 | 12736830 | 4 | Acute lymphocytic leukaemia |
| 127368301 | 12736830 | 5 | Acute lymphocytic leukaemia |
| 127368301 | 12736830 | 6 | Acute lymphocytic leukaemia |
| 127368301 | 12736830 | 7 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127368301 | 12736830 | HO |
| 127368301 | 12736830 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127368301 | 12736830 | Acute kidney injury | |
| 127368301 | 12736830 | Blood creatinine increased | |
| 127368301 | 12736830 | Device related infection |
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 |
|---|---|---|---|---|---|---|
| 127368301 | 12736830 | 1 | 20160205 | 0 |