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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125815112 | 12581511 | 2 | F | 20160611 | 20160802 | 20160721 | 20160805 | EXP | US-AMGEN-USASP2016092976 | AMGEN | 20.00 | YR | A | F | Y | 65.00000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125815112 | 12581511 | 1 | PS | NEUPOGEN | FILGRASTIM | 1 | Intravenous (not otherwise specified) | 350 MCG, 1X/DAY | 103353 | 350 | UG | UNKNOWN FORMULATION | QD | ||||||
| 125815112 | 12581511 | 2 | SS | GEMTUZUMAB OZOGAMICIN | GEMTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 5 MG, DAY 4,7,10 OF REINDUCTION THERAPY | 0 | 5 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 125815112 | 12581511 | 3 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 3500 MG, QD X 5 DOSES | 0 | 3500 | MG | QD | |||||||
| 125815112 | 12581511 | 4 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 50 MG, QD X 5 DOSES | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125815112 | 12581511 | 1 | Supportive care |
| 125815112 | 12581511 | 2 | Acute myeloid leukaemia recurrent |
| 125815112 | 12581511 | 3 | Acute myeloid leukaemia recurrent |
| 125815112 | 12581511 | 4 | Acute myeloid leukaemia recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125815112 | 12581511 | LT |
| 125815112 | 12581511 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125815112 | 12581511 | Acute kidney injury |
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 |
|---|---|---|---|---|---|---|
| 125815112 | 12581511 | 1 | 20160525 | 0 | ||
| 125815112 | 12581511 | 2 | 20160529 | 20160604 | 0 | |
| 125815112 | 12581511 | 3 | 20160526 | 0 | ||
| 125815112 | 12581511 | 4 | 20160526 | 0 |