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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120104318 | 12010431 | 8 | F | 20160127 | 20160831 | 20160205 | 20160908 | EXP | BE-ROCHE-1703014 | ROCHE | 86.40 | YR | F | Y | 86.00000 | KG | 20160908 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120104318 | 12010431 | 1 | PS | Trastuzumab Emtansine | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 125427 | 189 | MG | Q3W | ||||||||
| 120104318 | 12010431 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 120104318 | 12010431 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 534 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 120104318 | 12010431 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 125409 | 840 | MG | ||||||||
| 120104318 | 12010431 | 5 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 125409 | 420 | MG | Q3W | ||||||||
| 120104318 | 12010431 | 6 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120104318 | 12010431 | 1 | HER-2 positive breast cancer |
| 120104318 | 12010431 | 2 | HER-2 positive breast cancer |
| 120104318 | 12010431 | 4 | HER-2 positive breast cancer |
| 120104318 | 12010431 | 6 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120104318 | 12010431 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120104318 | 12010431 | 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 |
|---|---|---|---|---|---|---|
| 120104318 | 12010431 | 1 | 20141023 | 20160114 | 0 | |
| 120104318 | 12010431 | 2 | 20140407 | 20140407 | 0 | |
| 120104318 | 12010431 | 3 | 20140428 | 20140925 | 0 | |
| 120104318 | 12010431 | 4 | 20140407 | 20140407 | 0 | |
| 120104318 | 12010431 | 5 | 20140428 | 20140925 | 0 | |
| 120104318 | 12010431 | 6 | 20160128 | 20160205 | 0 |