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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295122 | 12529512 | 2 | F | 20160621 | 20160706 | 20160706 | EXP | JP-CIPLA LTD.-2011JP00151 | CIPLA | YANO R, KUROKAWA T, TSUYOSHI H, SHINAGAWA A, SAWAMURA Y, MATSUNAGA A ET AL.,. TRANSIENT ELEVATION OF INTERNATIONAL NORMALIZED RATIO DURING CISPLATIN-BASED CHEMOTHERAPY IN PATIENTS WHO ARE TAKING WARFARIN. THE ANNALS OF PHARMACOTHERAPY. 2011;45:E55 | 43.00 | YR | F | Y | 148.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295122 | 12529512 | 1 | PS | Warfarin | WARFARIN | 1 | Unknown | 1 MG/DAY | U | U | 90935 | 1 | MG | ||||||
| 125295122 | 12529512 | 2 | I | Warfarin | WARFARIN | 1 | Unknown | 2 MG/DAY, IN THE SECOND CYCLE | U | U | 90935 | 2 | MG | ||||||
| 125295122 | 12529512 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK, 4 CYCLES | 0 | ||||||||||
| 125295122 | 12529512 | 4 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 60 MG/M2, ON DAYS 1, 8, AND 15, EVERY 4 WEEKS | U | U | 0 | 60 | MG/M**2 | ||||||
| 125295122 | 12529512 | 5 | I | CISPLATIN. | CISPLATIN | 1 | Unknown | 60 MG/M2, ON DAY 1 EVERY 4 WEEKS | U | U | 0 | 60 | MG/M**2 | ||||||
| 125295122 | 12529512 | 6 | SS | Granisetron | GRANISETRON | 1 | Unknown | 3 MG, ON DAYS 1, 8, AND 15 | U | U | 0 | 3 | MG | ||||||
| 125295122 | 12529512 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | UNK | 0 | ||||||||||
| 125295122 | 12529512 | 8 | I | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 13.2 MG ON DAY 1 | U | U | 0 | 13.2 | MG | ||||||
| 125295122 | 12529512 | 9 | I | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 6.6 MG ON DAYS 2, 3, 8, AND 15 | U | U | 0 | 6.6 | MG | ||||||
| 125295122 | 12529512 | 10 | I | APREPITANT. | APREPITANT | 1 | Unknown | 125 MG ON DAYS 1, 8, AND 15 | U | U | 0 | 125 | MG | ||||||
| 125295122 | 12529512 | 11 | I | APREPITANT. | APREPITANT | 1 | 80 MG ON DAYS 2, 3, 9, 10, 16, AND 17 | U | U | 0 | 80 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125295122 | 12529512 | 1 | Thrombosis prophylaxis |
| 125295122 | 12529512 | 3 | Cervix cancer metastatic |
| 125295122 | 12529512 | 4 | Cervix cancer metastatic |
| 125295122 | 12529512 | 5 | Cervix cancer metastatic |
| 125295122 | 12529512 | 7 | Cervix cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125295122 | 12529512 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125295122 | 12529512 | Decreased appetite | |
| 125295122 | 12529512 | Drug interaction | |
| 125295122 | 12529512 | International normalised ratio increased | |
| 125295122 | 12529512 | Nausea | |
| 125295122 | 12529512 | Neoplasm progression | |
| 125295122 | 12529512 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |