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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127067552 | 12706755 | 2 | F | 20151029 | 20160919 | 20160901 | 20160927 | EXP | IT-JNJFOC-20160207954 | JANSSEN | 50.12 | YR | A | F | Y | 49.00000 | KG | 20160927 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127067552 | 12706755 | 1 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 1 | N | 0 | 1.6 | MG | INTRAVENOUS INFUSION | ||||||
| 127067552 | 12706755 | 2 | PS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 2 | N | 207953 | 1.58 | MG | INTRAVENOUS INFUSION | ||||||
| 127067552 | 12706755 | 3 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | CYCLE 1; 43 (UNITS NOT REPORTED) | N | 50718 | LIPOSOME INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127067552 | 12706755 | 1 | Ovarian cancer recurrent |
| 127067552 | 12706755 | 2 | Ovarian cancer recurrent |
| 127067552 | 12706755 | 3 | Ovarian cancer recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127067552 | 12706755 | HO |
| 127067552 | 12706755 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127067552 | 12706755 | Leukopenia | |
| 127067552 | 12706755 | 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 |
|---|---|---|---|---|---|---|
| 127067552 | 12706755 | 1 | 20151015 | 20151015 | 0 | |
| 127067552 | 12706755 | 2 | 20151106 | 20151106 | 0 | |
| 127067552 | 12706755 | 3 | 20151015 | 0 |