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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125894991 | 12589499 | 1 | I | 20160713 | 20160725 | 20160725 | EXP | JP-JNJFOC-20160717894 | JANSSEN | INOSE R, TAKAHASHI K, NISHIKAWA T, NAGAYAMA K. ANALYSIS OF THE FACTORS INFLUENCING THE DEVELOPMENT OF HAND-FOOT SYNDROME IN PATIENTS RECEIVING PEGYLATED LIPOSOMAL DOXORUBICIN THERAPY FOR OVARIAN CANCER. JAPANESE JOURNAL OF PHARMACEUTICAL HEALTH CARE AND SCIENCES JUN-2016;42(6):460-467. | 0.00 | Y | 0.00000 | 20160725 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125894991 | 12589499 | 1 | PS | DOXIL | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 50718 | LIPOSOME INJECTION | |||||||||
| 125894991 | 12589499 | 2 | C | REBAMIPIDE | REBAMIPIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 3 | C | SODIUM GUALENATE HYDRATE | SODIUM GUALENATE MONOHYDRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 4 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 6 | C | POVIDONE-IODINE. | POVIDONE-IODINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 7 | C | REGORAFENIB | REGORAFENIB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 8 | C | SORAFENIB | SORAFENIB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125894991 | 12589499 | 9 | C | PYRIDOXINE | PYRIDOXINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125894991 | 12589499 | 1 | Ovarian cancer |
| 125894991 | 12589499 | 3 | Stomatitis |
| 125894991 | 12589499 | 4 | Stomatitis |
| 125894991 | 12589499 | 5 | Stomatitis |
| 125894991 | 12589499 | 6 | Stomatitis |
| 125894991 | 12589499 | 7 | Colorectal cancer recurrent |
| 125894991 | 12589499 | 8 | Hepatocellular carcinoma |
| 125894991 | 12589499 | 9 | Palmar-plantar erythrodysaesthesia syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125894991 | 12589499 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125894991 | 12589499 | Alanine aminotransferase increased | |
| 125894991 | 12589499 | Anaemia | |
| 125894991 | 12589499 | Aspartate aminotransferase increased | |
| 125894991 | 12589499 | Blood bilirubin increased | |
| 125894991 | 12589499 | Blood creatinine increased | |
| 125894991 | 12589499 | Hypoalbuminaemia | |
| 125894991 | 12589499 | Neutropenia | |
| 125894991 | 12589499 | Palmar-plantar erythrodysaesthesia syndrome | |
| 125894991 | 12589499 | Platelet count decreased | |
| 125894991 | 12589499 | Stomatitis | |
| 125894991 | 12589499 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125894991 | 12589499 | 1 | 200904 | 201409 | 0 |