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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123946454 | 12394645 | 4 | F | 20141023 | 20160901 | 20160523 | 20160906 | EXP | IT-ROCHE-1761073 | ROCHE | 76.38 | YR | F | Y | 73.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123946454 | 12394645 | 1 | PS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 150 MG 1 VIAL FOR INTRAVENOUS USE, FORM :POWDER FOR CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSIO | Y | 103792 | 6 | UG/KG | SOLUTION FOR INFUSION | ||||||
| 123946454 | 12394645 | 2 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | RESTARTED?150 MG 1 VIAL FOR INTRAVENOUS USE, FORM :POWDER FOR CONCENTRATE FOR SOLUTION FOR INTRAVENO | Y | 103792 | 6 | UG/KG | SOLUTION FOR INFUSION | ||||||
| 123946454 | 12394645 | 3 | SS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | U | 125427 | 3.6 | MG/KG | SOLUTION FOR INFUSION | /cycle | ||||||
| 123946454 | 12394645 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | U | 103792 | SOLUTION FOR INJECTION | |||||||||
| 123946454 | 12394645 | 5 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | FREQUENCY: CYCLICAL | U | 0 | 800 | MG/M**2 | |||||||
| 123946454 | 12394645 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | FREQUENCY: CYCLICAL | U | 0 | 60 | MG/M**2 | |||||||
| 123946454 | 12394645 | 7 | C | MICARDIS | TELMISARTAN | 1 | 0 | ||||||||||||
| 123946454 | 12394645 | 8 | C | RYTMONORM | PROPAFENONE | 1 | 0 | ||||||||||||
| 123946454 | 12394645 | 9 | C | PARIET | RABEPRAZOLE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123946454 | 12394645 | 1 | HER-2 positive breast cancer |
| 123946454 | 12394645 | 3 | HER-2 positive breast cancer |
| 123946454 | 12394645 | 4 | HER-2 positive breast cancer |
| 123946454 | 12394645 | 5 | HER-2 positive breast cancer |
| 123946454 | 12394645 | 6 | Breast cancer |
| 123946454 | 12394645 | 7 | Hypertension |
| 123946454 | 12394645 | 8 | Hypertension |
| 123946454 | 12394645 | 9 | Gastritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123946454 | 12394645 | HO |
| 123946454 | 12394645 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123946454 | 12394645 | Arthralgia | |
| 123946454 | 12394645 | Cough | |
| 123946454 | 12394645 | Diarrhoea | |
| 123946454 | 12394645 | Dysphonia | |
| 123946454 | 12394645 | Dyspnoea exertional | |
| 123946454 | 12394645 | Ejection fraction decreased | |
| 123946454 | 12394645 | Myalgia | |
| 123946454 | 12394645 | Thrombocytopenia | |
| 123946454 | 12394645 | Vocal cord paralysis |
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 |
|---|---|---|---|---|---|---|
| 123946454 | 12394645 | 1 | 20130730 | 2014 | 0 | |
| 123946454 | 12394645 | 2 | 20150127 | 20160810 | 0 | |
| 123946454 | 12394645 | 3 | 20141106 | 20141127 | 0 | |
| 123946454 | 12394645 | 5 | 20130730 | 20141023 | 0 | |
| 123946454 | 12394645 | 6 | 20150720 | 20151111 | 0 |