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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127328461 | 12732846 | 1 | I | 20160113 | 20160830 | 20160912 | 20160912 | EXP | ZA-CIPLA LTD.-2016ZA18012 | CIPLA | 0.00 | Y | 0.00000 | 20160912 | OT | ZA | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127328461 | 12732846 | 1 | PS | Epirubicin | EPIRUBICIN | 1 | Unknown | UNK, 6 CYCLES | U | U | 0 | ||||||||
| 127328461 | 12732846 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK, 6 CYCLES | U | U | 0 | ||||||||
| 127328461 | 12732846 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, 6 CYCLES | U | 0 | |||||||||
| 127328461 | 12732846 | 4 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Intravenous (not otherwise specified) | 46 MG, ON DAY 1 AND DAY 8, 3 WEEKLY | 0 | 46 | MG | ||||||||
| 127328461 | 12732846 | 5 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Oral | UNK | 0 | ||||||||||
| 127328461 | 12732846 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | UNK, 6 CYCLES | U | U | 0 | ||||||||
| 127328461 | 12732846 | 7 | SS | XELODA | CAPECITABINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127328461 | 12732846 | 8 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG | ||||||
| 127328461 | 12732846 | 9 | C | Decasone | 2 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127328461 | 12732846 | 1 | Invasive ductal breast carcinoma |
| 127328461 | 12732846 | 2 | Invasive ductal breast carcinoma |
| 127328461 | 12732846 | 3 | Invasive ductal breast carcinoma |
| 127328461 | 12732846 | 4 | Breast cancer metastatic |
| 127328461 | 12732846 | 6 | Breast cancer metastatic |
| 127328461 | 12732846 | 7 | Breast cancer metastatic |
| 127328461 | 12732846 | 8 | Antiemetic supportive care |
| 127328461 | 12732846 | 9 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127328461 | 12732846 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127328461 | 12732846 | Disease progression | |
| 127328461 | 12732846 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 127328461 | 12732846 | 4 | 20151125 | 20160203 | 0 | |
| 127328461 | 12732846 | 5 | 20160203 | 0 | ||
| 127328461 | 12732846 | 8 | 20151125 | 20160203 | 0 | |
| 127328461 | 12732846 | 9 | 20151125 | 20160203 | 0 |