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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127229481 | 12722948 | 1 | I | 20160803 | 20160829 | 20160908 | 20160908 | EXP | GXBR2016US002712 | SANDOZ | 32.91 | YR | F | Y | 63.00000 | KG | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127229481 | 12722948 | 1 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 53 MG (TOTAL DOSE) | 22137 | 53 | MG | INJECTION | |||||||
| 127229481 | 12722948 | 2 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 3520 MG (TOTAL DOSE) | 0 | 3520 | MG | ||||||||
| 127229481 | 12722948 | 3 | SS | IDARUBICIN | IDARUBICIN | 1 | Intravenous (not otherwise specified) | 18 MG (TOTAL DOSE) | 0 | 18 | MG | ||||||||
| 127229481 | 12722948 | 4 | SS | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Subcutaneous | 480 UG (TOTAL DOSE) | 0 | 480 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127229481 | 12722948 | 1 | Acute myeloid leukaemia |
| 127229481 | 12722948 | 2 | Acute myeloid leukaemia |
| 127229481 | 12722948 | 3 | Acute myeloid leukaemia |
| 127229481 | 12722948 | 4 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127229481 | 12722948 | OT |
| 127229481 | 12722948 | HO |
| 127229481 | 12722948 | LT |
| 127229481 | 12722948 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127229481 | 12722948 | Bacteraemia | |
| 127229481 | 12722948 | Febrile neutropenia | |
| 127229481 | 12722948 | Hypoxia | |
| 127229481 | 12722948 | Pneumonia | |
| 127229481 | 12722948 | Pulmonary haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 127229481 | 12722948 | 1 | 20160716 | 20160720 | 0 | |
| 127229481 | 12722948 | 2 | 20160716 | 20160720 | 0 | |
| 127229481 | 12722948 | 3 | 20160717 | 20160718 | 0 | |
| 127229481 | 12722948 | 4 | 20160715 | 20160719 | 0 |