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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126243211 | 12624321 | 1 | I | 20160724 | 20160728 | 20160805 | 20160805 | EXP | US-ROCHE-1804579 | ROCHE | 44.00 | YR | F | Y | 0.00000 | 20160805 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126243211 | 12624321 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Unknown | U | 125409 | 420 | MG | ||||||||
| 126243211 | 12624321 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | U | 103792 | 550 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 126243211 | 12624321 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2 WEEKS ON-1 WEEK OFF | U | 0 | 1900 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126243211 | 12624321 | 1 | HER-2 positive breast cancer |
| 126243211 | 12624321 | 2 | HER-2 positive breast cancer |
| 126243211 | 12624321 | 3 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126243211 | 12624321 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126243211 | 12624321 | Diarrhoea | |
| 126243211 | 12624321 | Eye pain | |
| 126243211 | 12624321 | Headache | |
| 126243211 | 12624321 | Photophobia | |
| 126243211 | 12624321 | Pyrexia | |
| 126243211 | 12624321 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126243211 | 12624321 | 1 | 20160715 | 0 | ||
| 126243211 | 12624321 | 2 | 20160715 | 0 | ||
| 126243211 | 12624321 | 3 | 20160722 | 0 |