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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127637491 | 12763749 | 1 | I | 20151116 | 20160118 | 20160920 | 20160920 | EXP | IT-JNJFOC-20160208398 | JANSSEN | 51.78 | YR | A | F | Y | 60.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127637491 | 12763749 | 1 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | 1.58 (UNSPECIFIED UNITS) CYCLE 7 | Y | U | 0 | 1.58 | MG | INTRAVENOUS INFUSION | |||||
| 127637491 | 12763749 | 2 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 6 | Y | U | 0 | 1.5 | MG | INTRAVENOUS INFUSION | |||||
| 127637491 | 12763749 | 3 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 1 | Y | U | 0 | 1.85 | MG | INTRAVENOUS INFUSION | |||||
| 127637491 | 12763749 | 4 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | 1.85 (UNSPECIFIED UNITS) | Y | U | 0 | INTRAVENOUS INFUSION | |||||||
| 127637491 | 12763749 | 5 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 1.85 | MG | INTRAVENOUS INFUSION | ||||||
| 127637491 | 12763749 | 6 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 5 | Y | U | 0 | 1.85 | MG | INTRAVENOUS INFUSION | |||||
| 127637491 | 12763749 | 7 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 2 | Y | U | 0 | 1.85 | MG | INTRAVENOUS INFUSION | |||||
| 127637491 | 12763749 | 8 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | 1.46 (UNSPECIFIED UNITS) | Y | U | 0 | INTRAVENOUS INFUSION | |||||||
| 127637491 | 12763749 | 9 | PS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | 1.46 (UNSPECIFIED UNITS) | Y | U | 207953 | INTRAVENOUS INFUSION | |||||||
| 127637491 | 12763749 | 10 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 40 (UNITS AND FREQUENCY WAS NOT REPORTED); CYCLE 7 | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 11 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 38 (UNITS AND FREQUENCY WAS NOT REPORTED); CYCLE 6 | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 12 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | CYCLE 1; 50 (UNITS AND FREQUENCY WAS NOT REPORTED) | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 13 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 50 (UNITS AND FREQUENCY WAS NOT REPORTED) | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 14 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 39 (UNSPECIFIED UNITS) | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 15 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 39 (UNSPECIFIED UNITS) | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 16 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 38 (UNITS AND FREQUENCY WAS NOT REPORTED); CYCLE 5 | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 17 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 38 (UNITS AND FREQUENCY WAS NOT REPORTED) | Y | U | 0 | LIPOSOME INJECTION | |||||||
| 127637491 | 12763749 | 18 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 50 (UNSPECIFIED UNITS) | Y | U | 50718 | LIPOSOME INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127637491 | 12763749 | 1 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 2 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 3 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 4 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 5 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 6 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 7 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 8 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 9 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 10 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 11 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 12 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 13 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 14 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 15 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 16 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 17 | Ovarian cancer recurrent |
| 127637491 | 12763749 | 18 | Ovarian cancer recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127637491 | 12763749 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127637491 | 12763749 | Anal pruritus | |
| 127637491 | 12763749 | Blood creatine phosphokinase | |
| 127637491 | 12763749 | Hypertransaminasaemia | |
| 127637491 | 12763749 | Mucosal inflammation | |
| 127637491 | 12763749 | Neutropenia | |
| 127637491 | 12763749 | Palmar-plantar erythrodysaesthesia syndrome |
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 |
|---|---|---|---|---|---|---|
| 127637491 | 12763749 | 1 | 20160303 | 20160303 | 0 | |
| 127637491 | 12763749 | 2 | 20160211 | 0 | ||
| 127637491 | 12763749 | 3 | 20151117 | 0 | ||
| 127637491 | 12763749 | 4 | 20151210 | 20151210 | 0 | |
| 127637491 | 12763749 | 5 | 20151027 | 0 | ||
| 127637491 | 12763749 | 6 | 20160121 | 20160121 | 0 | |
| 127637491 | 12763749 | 7 | 20151230 | 20151230 | 0 | |
| 127637491 | 12763749 | 8 | 20160610 | 20160610 | 0 | |
| 127637491 | 12763749 | 9 | 20160518 | 20160518 | 0 | |
| 127637491 | 12763749 | 10 | 20160303 | 0 | ||
| 127637491 | 12763749 | 11 | 20160211 | 0 | ||
| 127637491 | 12763749 | 12 | 20151117 | 0 | ||
| 127637491 | 12763749 | 13 | 20151027 | 0 | ||
| 127637491 | 12763749 | 14 | 20160610 | 20160610 | 0 | |
| 127637491 | 12763749 | 15 | 20160518 | 20160518 | 0 | |
| 127637491 | 12763749 | 16 | 20160121 | 20160121 | 0 | |
| 127637491 | 12763749 | 17 | 20151230 | 20151230 | 0 | |
| 127637491 | 12763749 | 18 | 20151210 | 20151210 | 0 |