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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614831 | 12561483 | 1 | I | 201009 | 20130430 | 20160715 | 20160715 | EXP | JP-CIPLA LTD.-2013JP00427 | CIPLA | MIKAWA T, KOYAMA T, GOMI D, NAGURA K, MATSUDA M, SEKI R ET AL.,. LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE BUTTOCKS, WHICH HAD COMPLETE REMISSION INDUCED BY CHEMORADIOTHERAPY WITH CARBOPLATIN.. JPN J CANCER CHEMOTHER. 2013;40 (3):401 TO 403 | 0.00 | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614831 | 12561483 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 2 (WEEKLY),UNK | 0 | ||||||||||
| 125614831 | 12561483 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 5 DAY 1, Q 28 DAYS | 0 | ||||||||||
| 125614831 | 12561483 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 30 MG/M2, UNK | U | 0 | 30 | MG/M**2 | |||||||
| 125614831 | 12561483 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 1000 MG/M2, DAY 1 TO 4, Q 28 DAYS | 0 | 1000 | MG/M**2 | ||||||||
| 125614831 | 12561483 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 1000 MG/M2, UNK, 1 TO 4 FOR 4 WEEKS | 0 | 1000 | MG/M**2 | |||||||||
| 125614831 | 12561483 | 6 | SS | TS-1 | GIMERACILOTERACILTEGAFUR | 1 | Unknown | 80 MG/BODY/DAY, FOR 24 DAYS | 0 | 80 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125614831 | 12561483 | 1 | Squamous cell carcinoma |
| 125614831 | 12561483 | 3 | Squamous cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125614831 | 12561483 | DE |
| 125614831 | 12561483 | HO |
| 125614831 | 12561483 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125614831 | 12561483 | Activities of daily living impaired | |
| 125614831 | 12561483 | Cellulitis | |
| 125614831 | 12561483 | Dementia | |
| 125614831 | 12561483 | Disease progression | |
| 125614831 | 12561483 | Gastrointestinal haemorrhage | |
| 125614831 | 12561483 | Joint contracture | |
| 125614831 | 12561483 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |