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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125875171 | 12587517 | 1 | I | 201311 | 20131220 | 20160725 | 20160725 | EXP | DE-ROCHE-1324283 | ROCHE | 59.34 | YR | F | Y | 57.70000 | KG | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125875171 | 12587517 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE AS PER PROTOCOL | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | ||||||
| 125875171 | 12587517 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE?LAST DOSE TAKEN PRIOR TO SAE: 05/SEP/2013 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 125875171 | 12587517 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE TAKEN PRIOR TO SAE: 29/NOV/2012 | 0 | 80 | MG/M**2 | INFUSION | Q3W | ||||||
| 125875171 | 12587517 | 4 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE TAKEN PRIOR TO SAE: 23/AUG/2012 | 0 | 90 | MG/M**2 | INFUSION | Q3W | ||||||
| 125875171 | 12587517 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE TAKEN PRIOR TO SAE: 23/AUG/2012 | 0 | 600 | MG/M**2 | INFUSION | Q3W | ||||||
| 125875171 | 12587517 | 6 | C | LETROZOL | LETROZOLE | 1 | Unknown | 0 | |||||||||||
| 125875171 | 12587517 | 7 | C | L-THYROXIN | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | |||||||||||
| 125875171 | 12587517 | 8 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125875171 | 12587517 | 9 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE TAKEN PRIOR TO SAE: 05/SEP/2013 | 185965 | 0 | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125875171 | 12587517 | 1 | HER-2 positive breast cancer |
| 125875171 | 12587517 | 3 | HER-2 positive breast cancer |
| 125875171 | 12587517 | 4 | HER-2 positive breast cancer |
| 125875171 | 12587517 | 5 | HER-2 positive breast cancer |
| 125875171 | 12587517 | 9 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125875171 | 12587517 | DE |
| 125875171 | 12587517 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125875171 | 12587517 | Cardiac failure |
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 |
|---|---|---|---|---|---|---|
| 125875171 | 12587517 | 1 | 20120913 | 20120913 | 0 | |
| 125875171 | 12587517 | 2 | 20130905 | 0 | ||
| 125875171 | 12587517 | 3 | 20120913 | 20121129 | 0 | |
| 125875171 | 12587517 | 4 | 20120621 | 20120823 | 0 | |
| 125875171 | 12587517 | 5 | 20120621 | 20120823 | 0 | |
| 125875171 | 12587517 | 6 | 2012 | 0 | ||
| 125875171 | 12587517 | 7 | 2011 | 0 | ||
| 125875171 | 12587517 | 9 | 20120913 | 20130905 | 0 |