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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123214502 | 12321450 | 2 | F | 20141014 | 20160705 | 20160502 | 20160708 | EXP | DE-ROCHE-1518141 | ROCHE | 52.00 | YR | F | Y | 79.00000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123214502 | 12321450 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | B1002,B1004,B0031,B1007,B1006,B1008 | 103792 | 600 | MG | Q3W | |||||||
| 123214502 | 12321450 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | U | 0 | 80 | MG/M**2 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123214502 | 12321450 | 1 | Breast cancer |
| 123214502 | 12321450 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123214502 | 12321450 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123214502 | 12321450 | Alveolitis | |
| 123214502 | 12321450 | Ascites | |
| 123214502 | 12321450 | Balance disorder | |
| 123214502 | 12321450 | Constipation | |
| 123214502 | 12321450 | Disturbance in attention | |
| 123214502 | 12321450 | Dizziness | |
| 123214502 | 12321450 | Dyspnoea | |
| 123214502 | 12321450 | Epistaxis | |
| 123214502 | 12321450 | Fatigue | |
| 123214502 | 12321450 | General physical health deterioration | |
| 123214502 | 12321450 | Haematoma | |
| 123214502 | 12321450 | Injection site pain | |
| 123214502 | 12321450 | Insomnia | |
| 123214502 | 12321450 | Malnutrition | |
| 123214502 | 12321450 | Mental impairment | |
| 123214502 | 12321450 | Muscle twitching | |
| 123214502 | 12321450 | Oedema peripheral | |
| 123214502 | 12321450 | Pain | |
| 123214502 | 12321450 | Paraesthesia | |
| 123214502 | 12321450 | Skin exfoliation |
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 |
|---|---|---|---|---|---|---|
| 123214502 | 12321450 | 1 | 20140929 | 20150916 | 0 | |
| 123214502 | 12321450 | 2 | 20140930 | 20141202 | 0 |