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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127502191 | 12750219 | 1 | I | 20160322 | 20160901 | 20160916 | 20160916 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-01795 | WESTWARD | 61.00 | YR | F | Y | 96.16000 | KG | 20160916 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127502191 | 12750219 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | Y | 76099 | 701 | MG | ||||||||
| 127502191 | 12750219 | 2 | SS | FARLETUZUMAB | FARLETUZUMAB | 1 | Intravenous drip | 0 | 10 | MG/KG | /wk | ||||||||
| 127502191 | 12750219 | 3 | SS | FARLETUZUMAB | FARLETUZUMAB | 1 | Intravenous drip | 0 | 10 | MG/KG | /wk | ||||||||
| 127502191 | 12750219 | 4 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Unknown | 0 | |||||||||||
| 127502191 | 12750219 | 5 | SS | DOXIL | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 66.3 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127502191 | 12750219 | 1 | Ovarian cancer |
| 127502191 | 12750219 | 2 | Ovarian cancer |
| 127502191 | 12750219 | 4 | Ovarian cancer |
| 127502191 | 12750219 | 5 | Ovarian cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127502191 | 12750219 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127502191 | 12750219 | Dizziness | |
| 127502191 | 12750219 | Sinus congestion | |
| 127502191 | 12750219 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127502191 | 12750219 | 1 | 20151117 | 0 | ||
| 127502191 | 12750219 | 2 | 20151117 | 20151201 | 0 | |
| 127502191 | 12750219 | 3 | 20151208 | 0 | ||
| 127502191 | 12750219 | 4 | 20151117 | 0 | ||
| 127502191 | 12750219 | 5 | 20151117 | 0 |