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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113812079 | 11381207 | 9 | F | 20150625 | 20160923 | 20150814 | 20160927 | EXP | DE-ROCHE-1619073 | ROCHE | 56.00 | YR | F | Y | 85.00000 | KG | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113812079 | 11381207 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | U | B1008 | 103792 | 600 | MG | SOLUTION FOR INJECTION | Q3W | |||||
| 113812079 | 11381207 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | D | 0 | 175 | MG/M**2 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113812079 | 11381207 | 1 | HER-2 positive breast cancer |
| 113812079 | 11381207 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113812079 | 11381207 | DE |
| 113812079 | 11381207 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113812079 | 11381207 | Abdominal pain lower | |
| 113812079 | 11381207 | Dry mouth | |
| 113812079 | 11381207 | Dry skin | |
| 113812079 | 11381207 | Endometriosis | |
| 113812079 | 11381207 | Faecaloma | |
| 113812079 | 11381207 | General physical health deterioration | |
| 113812079 | 11381207 | Glioblastoma | |
| 113812079 | 11381207 | Injection site discolouration | |
| 113812079 | 11381207 | Injection site erythema | |
| 113812079 | 11381207 | Injection site haematoma | |
| 113812079 | 11381207 | Injection site pain | |
| 113812079 | 11381207 | Muscle spasms | |
| 113812079 | 11381207 | Pain in extremity | |
| 113812079 | 11381207 | Rhinorrhoea | |
| 113812079 | 11381207 | Scab | |
| 113812079 | 11381207 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 113812079 | 11381207 | 1 | 20150625 | 20160701 | 0 | |
| 113812079 | 11381207 | 2 | 20150624 | 20150806 | 0 |