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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124880032 | 12488003 | 2 | F | 20160427 | 20160725 | 20160622 | 20160728 | EXP | GB-ACTAVIS-2016-13015 | ACTAVIS | 0.00 | F | Y | 0.00000 | 20160728 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124880032 | 12488003 | 1 | PS | Epirubicin (Unknown) | EPIRUBICIN | 1 | Unknown | UNK UNK, UNKNOWN | UNCONFIRMED | 65445 | UNK | ||||||||
| 124880032 | 12488003 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK UNK, UNKNOWN | 0 | ||||||||||
| 124880032 | 12488003 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK UNK, UNKNOWN | 0 | ||||||||||
| 124880032 | 12488003 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | 600 MG, 1/ THREE WEEKS | U | 0 | 600 | MG | Q3W | ||||||
| 124880032 | 12488003 | 5 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 124880032 | 12488003 | 6 | C | LETROZOLE. | LETROZOLE | 1 | Oral | 2.9 MG, DAILY | U | 0 | 2.9 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124880032 | 12488003 | 1 | Breast cancer |
| 124880032 | 12488003 | 2 | Breast cancer |
| 124880032 | 12488003 | 3 | Breast cancer |
| 124880032 | 12488003 | 4 | Breast cancer |
| 124880032 | 12488003 | 5 | Breast cancer |
| 124880032 | 12488003 | 6 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124880032 | 12488003 | OT |
| 124880032 | 12488003 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124880032 | 12488003 | Colitis | |
| 124880032 | 12488003 | Colitis ulcerative | |
| 124880032 | 12488003 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 124880032 | 12488003 | 4 | 20150826 | 20160504 | 0 | |
| 124880032 | 12488003 | 6 | 201510 | 0 |