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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109648479 | 10964847 | 9 | F | 20150212 | 20160916 | 20150330 | 20160920 | EXP | DE-ROCHE-1555105 | ROCHE | 57.00 | YR | F | Y | 77.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109648479 | 10964847 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | B0031,B1006,B1007,B1008 | 103792 | 600 | MG | SOLUTION FOR INJECTION | Q3W | ||||||
| 109648479 | 10964847 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG/M**2 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109648479 | 10964847 | 1 | HER-2 positive breast cancer |
| 109648479 | 10964847 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109648479 | 10964847 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109648479 | 10964847 | Alanine aminotransferase increased | |
| 109648479 | 10964847 | Aspartate aminotransferase increased | |
| 109648479 | 10964847 | Bone pain | |
| 109648479 | 10964847 | Dermatitis allergic | |
| 109648479 | 10964847 | Diarrhoea | |
| 109648479 | 10964847 | Dizziness | |
| 109648479 | 10964847 | Dyspnoea | |
| 109648479 | 10964847 | General physical health deterioration | |
| 109648479 | 10964847 | Hypokalaemia | |
| 109648479 | 10964847 | Injection site erythema | |
| 109648479 | 10964847 | Injection site swelling | |
| 109648479 | 10964847 | Joint instability | |
| 109648479 | 10964847 | Malnutrition | |
| 109648479 | 10964847 | Nail discolouration | |
| 109648479 | 10964847 | Nail discomfort | |
| 109648479 | 10964847 | Oedema peripheral | |
| 109648479 | 10964847 | Pericardial effusion | |
| 109648479 | 10964847 | Peripheral swelling | |
| 109648479 | 10964847 | Photosensitivity reaction | |
| 109648479 | 10964847 | Rash | |
| 109648479 | 10964847 | Sleep disorder | |
| 109648479 | 10964847 | Vomiting | |
| 109648479 | 10964847 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 109648479 | 10964847 | 1 | 20150212 | 20160208 | 0 | |
| 109648479 | 10964847 | 2 | 20150213 | 20150518 | 0 |