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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125387401 | 12538740 | 1 | I | 201603 | 20160624 | 20160708 | 20160708 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-01174 | WESTWARD | 69.42 | YR | M | Y | 88.00000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125387401 | 12538740 | 1 | PS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 71472 | |||||||||||
| 125387401 | 12538740 | 2 | SS | IDARUBICIN | IDARUBICIN | 1 | Unknown | 65275 | |||||||||||
| 125387401 | 12538740 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125387401 | 12538740 | 4 | SS | MYLOTARG | GEMTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0 | 6.3 | MG | |||||||||
| 125387401 | 12538740 | 5 | C | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125387401 | 12538740 | 1 | Acute myeloid leukaemia |
| 125387401 | 12538740 | 2 | Acute myeloid leukaemia |
| 125387401 | 12538740 | 3 | Acute myeloid leukaemia |
| 125387401 | 12538740 | 4 | Acute myeloid leukaemia |
| 125387401 | 12538740 | 5 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125387401 | 12538740 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125387401 | 12538740 | Cholecystitis acute | |
| 125387401 | 12538740 | Diverticulitis | |
| 125387401 | 12538740 | Escherichia bacteraemia | |
| 125387401 | 12538740 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 125387401 | 12538740 | 1 | 20160228 | 20160301 | 0 | |
| 125387401 | 12538740 | 2 | 20160228 | 20160301 | 0 | |
| 125387401 | 12538740 | 3 | 20160227 | 20160229 | 0 | |
| 125387401 | 12538740 | 4 | 20160302 | 20160302 | 0 |