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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126202844 | 12620284 | 4 | F | 20141023 | 20160902 | 20160803 | 20160914 | EXP | IT-MINISAL02-368202 | IT-TEVA-680430ACC | TEVA | 76.38 | YR | F | Y | 73.00000 | KG | 20160914 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126202844 | 12620284 | 1 | PS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 60 MG/M2 CYCLICAL | Y | 75297 | 60 | MG/M**2 | SOLUTION FOR INFUSION | ||||||
| 126202844 | 12620284 | 2 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2 CYCLICAL | Y | 77983 | 800 | MG/M**2 | |||||||
| 126202844 | 12620284 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6 UG/KG CYCLICAL | 0 | 6 | UG/KG | ||||||||
| 126202844 | 12620284 | 4 | SS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 3.6 MG/KG CYCLICAL | Y | 0 | 3.6 | MG/KG | |||||||
| 126202844 | 12620284 | 5 | C | MICARDIS | TELMISARTAN | 1 | U | 0 | |||||||||||
| 126202844 | 12620284 | 6 | C | RYTMONORM | PROPAFENONE | 1 | U | 0 | |||||||||||
| 126202844 | 12620284 | 7 | C | PARIET | RABEPRAZOLE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126202844 | 12620284 | 1 | Breast cancer |
| 126202844 | 12620284 | 2 | Breast cancer |
| 126202844 | 12620284 | 3 | Breast cancer |
| 126202844 | 12620284 | 4 | Breast cancer |
| 126202844 | 12620284 | 5 | Hypertension |
| 126202844 | 12620284 | 6 | Hypertension |
| 126202844 | 12620284 | 7 | Gastritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126202844 | 12620284 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126202844 | 12620284 | Diarrhoea | |
| 126202844 | 12620284 | Dyspnoea exertional | |
| 126202844 | 12620284 | Ejection fraction decreased | |
| 126202844 | 12620284 | Myalgia | |
| 126202844 | 12620284 | Thrombocytopenia | |
| 126202844 | 12620284 | 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 |
|---|---|---|---|---|---|---|
| 126202844 | 12620284 | 1 | 20150720 | 20151111 | 0 | |
| 126202844 | 12620284 | 2 | 20130730 | 20141023 | 0 | |
| 126202844 | 12620284 | 3 | 20130730 | 20160810 | 0 | |
| 126202844 | 12620284 | 4 | 20141106 | 20141127 | 0 |