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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295162 | 12529516 | 2 | F | 20160621 | 20160706 | 20160706 | EXP | JP-CIPLA LTD.-2011JP00150 | CIPLA | YANO R, KUROKAWA T, TSUYOSHI H, SHINAGAW 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 | 0.00 | Y | 0.00000 | 20160706 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295162 | 12529516 | 1 | I | Warfarin | WARFARIN | 1 | Unknown | 3.25 MG/ DAY | U | U | 0 | 3.25 | MG | ||||||
| 125295162 | 12529516 | 2 | I | Warfarin | WARFARIN | 1 | Unknown | 3 MG/ DAY ON DAY 4 | U | U | 0 | 3 | MG | ||||||
| 125295162 | 12529516 | 3 | I | Warfarin | WARFARIN | 1 | Unknown | 3.75 MG/ DAY (INCREASED) | U | U | 0 | 3.75 | MG | ||||||
| 125295162 | 12529516 | 4 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | 60 MG/M2, ON DAYS 1, 8 AND 15, EVERY 4 WEEKS, 2 CYCLES | U | 77219 | 60 | MG/M**2 | |||||||
| 125295162 | 12529516 | 5 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK, SECOND CYCLE | U | 77219 | |||||||||
| 125295162 | 12529516 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK, THREE CYCLES | 0 | ||||||||||
| 125295162 | 12529516 | 7 | I | CISPLATIN. | CISPLATIN | 1 | Unknown | 60 MG/M2, ON DAY 1, EVER 4 WEEKS, TWO CYCLES | U | 0 | 60 | MG/M**2 | |||||||
| 125295162 | 12529516 | 8 | I | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, SECOND CYCLE | U | 0 | |||||||||
| 125295162 | 12529516 | 9 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | UNK, THREE CYCLES | 0 | ||||||||||
| 125295162 | 12529516 | 10 | SS | Granisetron | GRANISETRON | 1 | Unknown | 3 MG, ON DAYS 1, 8 AND 15 | U | U | 0 | 3 | MG | ||||||
| 125295162 | 12529516 | 11 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | 100 MG DAILY, INITIATED 3 DAYS BEFORE CHEMOTHERAPY | U | U | 0 | 100 | MG | ||||||
| 125295162 | 12529516 | 12 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 13.2 MG, ON DAY 1 | U | U | 0 | 13.2 | MG | ||||||
| 125295162 | 12529516 | 13 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 6.6 MG, DAYS 2, 3, 8 AND 15 | U | U | 0 | 6.6 | MG | ||||||
| 125295162 | 12529516 | 14 | I | APREPITANT. | APREPITANT | 1 | Unknown | 125 MG, ON DAY 1 | U | U | 0 | 125 | MG | ||||||
| 125295162 | 12529516 | 15 | I | APREPITANT. | APREPITANT | 1 | Unknown | 80 MG, ON DAYS 2 AND 3 | U | U | 0 | 80 | MG | ||||||
| 125295162 | 12529516 | 16 | SS | HEPARIN | HEPARIN SODIUM | 1 | Unknown | UNK, CONTINOUS | U | U | 0 | ||||||||
| 125295162 | 12529516 | 17 | SS | HEPARIN | HEPARIN SODIUM | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125295162 | 12529516 | 1 | Disseminated intravascular coagulation |
| 125295162 | 12529516 | 2 | Deep vein thrombosis |
| 125295162 | 12529516 | 4 | Ovarian cancer |
| 125295162 | 12529516 | 6 | Ovarian cancer |
| 125295162 | 12529516 | 7 | Ovarian cancer |
| 125295162 | 12529516 | 9 | Ovarian cancer |
| 125295162 | 12529516 | 16 | Disseminated intravascular coagulation |
| 125295162 | 12529516 | 17 | Deep vein thrombosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125295162 | 12529516 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125295162 | 12529516 | Decreased appetite | |
| 125295162 | 12529516 | Drug interaction | |
| 125295162 | 12529516 | International normalised ratio increased | |
| 125295162 | 12529516 | Nausea | |
| 125295162 | 12529516 | Therapy non-responder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |