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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1117696012 | 11176960 | 12 | F | 20150421 | 20160825 | 20150610 | 20160826 | EXP | DE-ROCHE-1567215 | ROCHE | 75.64 | YR | F | Y | 96.20000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1117696012 | 11176960 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | Y | U | 20150200032,20150300064,20150300176 | 103792 | 600 | MG | SOLUTION FOR INJECTION | Q3W | ||||
| 1117696012 | 11176960 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | Y | U | 20150200032,20150300064,20150300176 | 103792 | 600 | MG | SOLUTION FOR INJECTION | |||||
| 1117696012 | 11176960 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | Y | U | 20150200032,20150300064,20150300176 | 103792 | 600 | MG | SOLUTION FOR INJECTION | |||||
| 1117696012 | 11176960 | 4 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 125 | MG/M**2 | /wk | ||||||||
| 1117696012 | 11176960 | 5 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1117696012 | 11176960 | 6 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1117696012 | 11176960 | 7 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1117696012 | 11176960 | 8 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1117696012 | 11176960 | 9 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1117696012 | 11176960 | 10 | C | DEXAMETHASON | DEXAMETHASONE | 1 | Oral | 0 | 8 | MG | /wk | ||||||||
| 1117696012 | 11176960 | 11 | C | AMLODIPIN | AMLODIPINE BESYLATE | 1 | Oral | 0 | 10 | MG | |||||||||
| 1117696012 | 11176960 | 12 | C | VALSARTAN COMP | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 320/25 MG | 0 | BID | |||||||||
| 1117696012 | 11176960 | 13 | C | XARELTO | RIVAROXABAN | 1 | 0 | ||||||||||||
| 1117696012 | 11176960 | 14 | C | ACTRAPID | INSULIN HUMAN | 1 | 0 | ||||||||||||
| 1117696012 | 11176960 | 15 | C | PROTAPHANE | INSULIN HUMAN | 1 | 0 | ||||||||||||
| 1117696012 | 11176960 | 16 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1117696012 | 11176960 | 1 | Breast cancer |
| 1117696012 | 11176960 | 4 | Breast cancer |
| 1117696012 | 11176960 | 10 | Prophylaxis |
| 1117696012 | 11176960 | 11 | Hypertension |
| 1117696012 | 11176960 | 12 | Hypertension |
| 1117696012 | 11176960 | 13 | Atrial fibrillation |
| 1117696012 | 11176960 | 14 | Diabetes mellitus |
| 1117696012 | 11176960 | 15 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1117696012 | 11176960 | OT |
| 1117696012 | 11176960 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1117696012 | 11176960 | Atrial fibrillation | |
| 1117696012 | 11176960 | Cardiomyopathy | |
| 1117696012 | 11176960 | Dry eye | |
| 1117696012 | 11176960 | Nausea | |
| 1117696012 | 11176960 | Pulmonary hypertension | |
| 1117696012 | 11176960 | Right ventricular failure | |
| 1117696012 | 11176960 | Ventricular extrasystoles |
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 |
|---|---|---|---|---|---|---|
| 1117696012 | 11176960 | 1 | 20150217 | 0 | ||
| 1117696012 | 11176960 | 2 | 20150310 | 20150421 | 0 | |
| 1117696012 | 11176960 | 3 | 20150803 | 20160510 | 0 | |
| 1117696012 | 11176960 | 4 | 20150217 | 20150408 | 0 | |
| 1117696012 | 11176960 | 5 | 20150224 | 0 | ||
| 1117696012 | 11176960 | 6 | 20150303 | 0 | ||
| 1117696012 | 11176960 | 7 | 20150317 | 0 | ||
| 1117696012 | 11176960 | 8 | 20150324 | 0 | ||
| 1117696012 | 11176960 | 9 | 20150331 | 20150408 | 0 | |
| 1117696012 | 11176960 | 10 | 20150217 | 20150408 | 0 | |
| 1117696012 | 11176960 | 16 | 201504 | 0 |