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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122463045 | 12246304 | 5 | F | 20160325 | 20160714 | 20160407 | 20160719 | EXP | US-JNJFOC-20160400662 | JANSSEN | 73.51 | YR | E | F | Y | 63.50000 | KG | 20160719 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122463045 | 12246304 | 1 | PS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | Y | N | 4369255-6190 | 207953 | INTRAVENOUS INFUSION | |||||||
| 122463045 | 12246304 | 2 | SS | TRABECTEDIN | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | DAY 1, 1.1287 MG/M2 | Y | N | 4369255-6190 | 114938 | 1.93 | MG | INTRAVENOUS INFUSION | ||||
| 122463045 | 12246304 | 3 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | Y | N | 4371305-27108 | 50718 | LIPOSOME INJECTION | |||||||
| 122463045 | 12246304 | 4 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAY 1, 30.7018 MG/M2 | Y | N | 4371305-27108 | 36778 | 52.5 | MG | LIPOSOME INJECTION | ||||
| 122463045 | 12246304 | 5 | C | ASPRIN | ASPIRIN | 1 | Oral | 0 | 81 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 6 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 122463045 | 12246304 | 7 | C | CALCIUM 600 PLUS VITAMIN D | CALCIUM CARBONATEVITAMIN D | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 122463045 | 12246304 | 8 | C | CLARITIN | LORATADINE | 1 | Oral | 0 | 10 | MG | TABLET | ||||||||
| 122463045 | 12246304 | 9 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | 0 | 45 | MG | UNKNOWN | ||||||||
| 122463045 | 12246304 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 11 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 125 | UG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 13 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | DOSE: 2000 UNITS UNSPECIFIED | 0 | UNSPECIFIED | |||||||||
| 122463045 | 12246304 | 14 | C | MULTIVITAMINS | VITAMINS | 1 | Oral | 0 | 1 | DF | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 15 | C | COLACE | DOCUSATE SODIUM | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 16 | C | DULCOLAX NOS | BISACODYL OR DOCUSATE SODIUM | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 17 | C | MELATONIN | MELATONIN | 1 | Oral | 0 | 3 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 18 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 122463045 | 12246304 | 19 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122463045 | 12246304 | 2 | Ovarian cancer |
| 122463045 | 12246304 | 4 | Ovarian cancer |
| 122463045 | 12246304 | 12 | Hypothyroidism |
| 122463045 | 12246304 | 15 | Constipation |
| 122463045 | 12246304 | 16 | Constipation |
| 122463045 | 12246304 | 17 | Insomnia |
| 122463045 | 12246304 | 18 | Insomnia |
| 122463045 | 12246304 | 19 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122463045 | 12246304 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122463045 | 12246304 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 122463045 | 12246304 | 2 | 20160121 | 20160303 | 0 | |
| 122463045 | 12246304 | 4 | 20160121 | 20160303 | 0 |