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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125697632 | 12569763 | 2 | F | 20160627 | 20160721 | 20160719 | 20160802 | EXP | DE-CELGENEUS-DEU-2016070690 | CELGENE | 56.00 | YR | Y | 54.00000 | KG | 20160802 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125697632 | 12569763 | 1 | PS | ABRAXANE | PACLITAXEL | 1 | Intravenous drip | 21.4286 MILLIGRAM/SQ. METER | U | 21660 | 300 | MG/M**2 | INJECTION FOR INFUSION | QOW | |||||
| 125697632 | 12569763 | 2 | SS | trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | 28.5714 MILLIGRAM | U | U | 0 | 600 | MG | UNKNOWN | Q3W | ||||
| 125697632 | 12569763 | 3 | SS | epirubicin | EPIRUBICIN | 1 | Unknown | U | 0 | 150 | MG/M**2 | UNKNOWN | QOW | ||||||
| 125697632 | 12569763 | 4 | SS | cyclophosphamid | CYCLOPHOSPHAMIDE | 1 | Unknown | 10.7143 MILLIGRAM/SQ. METER | U | 0 | 2000 | MG/M**2 | UNKNOWN | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125697632 | 12569763 | 1 | Breast cancer |
| 125697632 | 12569763 | 2 | Breast cancer |
| 125697632 | 12569763 | 3 | Breast cancer |
| 125697632 | 12569763 | 4 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125697632 | 12569763 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125697632 | 12569763 | General physical health deterioration |
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 |
|---|---|---|---|---|---|---|
| 125697632 | 12569763 | 1 | 20150507 | 20150618 | 0 | |
| 125697632 | 12569763 | 2 | 20151015 | 0 | ||
| 125697632 | 12569763 | 3 | 20150326 | 20150423 | 0 | |
| 125697632 | 12569763 | 4 | 20150702 | 20150730 | 0 |