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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126229461 | 12622946 | 1 | I | 20131101 | 20131202 | 20160804 | 20160804 | EXP | DE-JNJFOC-20131200340 | JANSSEN | 66.42 | YR | E | F | Y | 74.00000 | KG | 20160804 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126229461 | 12622946 | 1 | PS | YONDELIS | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 3 | Y | N | UNKNOWN | 207953 | .9 | MG/M**2 | INTRAVENOUS INFUSION | ||||
| 126229461 | 12622946 | 2 | SS | YONDELIS | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | CYCLE 1 | Y | N | UNKNOWN | 114938 | .9 | MG/M**2 | INTRAVENOUS INFUSION | ||||
| 126229461 | 12622946 | 3 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | CYCLE 3 | Y | N | UNKNOWN | 50718 | LIPOSOME INJECTION | ||||||
| 126229461 | 12622946 | 4 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | CYCLE 1 | Y | N | UNKNOWN | 36778 | LIPOSOME INJECTION | ||||||
| 126229461 | 12622946 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | 2 | MG | UNSPECIFIED | ||||||||
| 126229461 | 12622946 | 6 | C | GRANISETRON | GRANISETRON | 1 | Unknown | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 126229461 | 12622946 | 7 | C | INNOHEP | TINZAPARIN SODIUM | 1 | Subcutaneous | 0 | .5 | ML | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126229461 | 12622946 | 1 | Ovarian cancer |
| 126229461 | 12622946 | 2 | Ovarian cancer |
| 126229461 | 12622946 | 3 | Ovarian cancer |
| 126229461 | 12622946 | 4 | Ovarian cancer |
| 126229461 | 12622946 | 5 | Premedication |
| 126229461 | 12622946 | 6 | Premedication |
| 126229461 | 12622946 | 7 | Anticoagulant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126229461 | 12622946 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126229461 | 12622946 | Deep vein thrombosis | |
| 126229461 | 12622946 | Embolism | |
| 126229461 | 12622946 | Embolism arterial | |
| 126229461 | 12622946 | Fatigue | |
| 126229461 | 12622946 | Pyrexia | |
| 126229461 | 12622946 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 126229461 | 12622946 | 1 | 20131001 | 0 | ||
| 126229461 | 12622946 | 2 | 20130910 | 0 | ||
| 126229461 | 12622946 | 3 | 20131001 | 0 | ||
| 126229461 | 12622946 | 4 | 20130910 | 0 |