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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127095211 | 12709521 | 1 | I | 20160829 | 20160902 | 20160902 | EXP | JP-MYLANLABS-2016M1037166 | MYLAN | ISHII S, UEDA T, HIGUCHI M, MIMA T, YAKUSHIJI N. COMBINATION CHEMOTHERAPY OF S-1, DOCETAXEL AND CDDP PRODUCES A REMARKABLE RESPONSE IN A PATIENT WITH METASTASES OF SUPRACLAVICULAR LYMPH NODES AND GINGIVAL CARCINOMA OF THE MANDIBLE. GAN-TO-KAGAKU-RYOHO 2010;37(9):1763-1765. | 0.00 | Y | 0.00000 | 20160902 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127095211 | 12709521 | 1 | PS | CISPLATIN. | CISPLATIN | 1 | Unknown | 10MG/M2 ON DAYS 1 AND 8 FOLLOWED BY AT LEAST 7 DAYS OF WITHDRAWAL | U | U | 91062 | ||||||||
| 127095211 | 12709521 | 2 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 35MG/M2 ON DAYS 1 AND 8 FOLLOWED BY AT LEAST 7 DAYS OF WITHDRAWAL | U | U | 0 | ||||||||
| 127095211 | 12709521 | 3 | SS | GIMERACIL W/OTERACIL POTASSIUM/TEGAFUR | GIMERACILOTERACILTEGAFUR | 1 | Unknown | 80MG ON DAYS 1-14 FOLLOWED BY AT LEAST 7 DAYS OF WITHDRAWAL | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127095211 | 12709521 | 1 | Metastatic squamous cell carcinoma |
| 127095211 | 12709521 | 2 | Metastatic squamous cell carcinoma |
| 127095211 | 12709521 | 3 | Metastatic squamous cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127095211 | 12709521 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127095211 | 12709521 | Alopecia | |
| 127095211 | 12709521 | Diarrhoea | |
| 127095211 | 12709521 | Mucosal inflammation | |
| 127095211 | 12709521 | 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 |
|---|---|---|---|---|---|---|
| 127095211 | 12709521 | 1 | 20071010 | 0 | ||
| 127095211 | 12709521 | 2 | 20071010 | 0 | ||
| 127095211 | 12709521 | 3 | 20071010 | 0 |