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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123960202 | 12396020 | 2 | F | 2014 | 20160727 | 20160524 | 20160801 | EXP | IT-ROCHE-1761071 | ROCHE | 0.00 | F | Y | 70.00000 | KG | 20160801 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123960202 | 12396020 | 1 | PS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | ROUTE: POWDER FOR SOLUTION FOR INTRAVENOUS INFUSION?150 MG 1 VIAL, INTRAVENOUS USE | U | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 123960202 | 12396020 | 2 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 123960202 | 12396020 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | ONE CYCLE | U | 0 | |||||||||
| 123960202 | 12396020 | 4 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | 0 | |||||||||||
| 123960202 | 12396020 | 5 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | 103792 | SOLUTION FOR INJECTION | ||||||||||
| 123960202 | 12396020 | 6 | C | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 123960202 | 12396020 | 7 | C | CONTRAMAL | TRAMADOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 123960202 | 12396020 | 8 | C | CO-EFFERALGAN | ACETAMINOPHENCODEINE PHOSPHATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123960202 | 12396020 | 1 | Breast cancer stage IV |
| 123960202 | 12396020 | 2 | Breast cancer stage IV |
| 123960202 | 12396020 | 3 | Product used for unknown indication |
| 123960202 | 12396020 | 4 | Product used for unknown indication |
| 123960202 | 12396020 | 5 | HER-2 positive breast cancer |
| 123960202 | 12396020 | 6 | Diabetes mellitus |
| 123960202 | 12396020 | 7 | Pain |
| 123960202 | 12396020 | 8 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123960202 | 12396020 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123960202 | 12396020 | Aphonia | |
| 123960202 | 12396020 | Balance disorder | |
| 123960202 | 12396020 | Bone pain | |
| 123960202 | 12396020 | Breast oedema | |
| 123960202 | 12396020 | Cholangitis | |
| 123960202 | 12396020 | Constipation | |
| 123960202 | 12396020 | Dyspnoea exertional | |
| 123960202 | 12396020 | Erythema | |
| 123960202 | 12396020 | Musculoskeletal pain | |
| 123960202 | 12396020 | Pain in extremity | |
| 123960202 | 12396020 | Pleural effusion | |
| 123960202 | 12396020 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 123960202 | 12396020 | 1 | 2015 | 0 | ||
| 123960202 | 12396020 | 2 | 2014 | 0 | ||
| 123960202 | 12396020 | 3 | 2014 | 0 | ||
| 123960202 | 12396020 | 4 | 2015 | 0 | ||
| 123960202 | 12396020 | 5 | 2015 | 2015 | 0 |