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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125073262 | 12507326 | 2 | F | 20160601 | 20160711 | 20160629 | 20160715 | PER | PHEH2016US015806 | NOVARTIS | 48.73 | YR | F | Y | 0.00000 | 20160715 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125073262 | 12507326 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | TABLET | QD | ||||||
| 125073262 | 12507326 | 2 | SS | LETROZOLE. | LETROZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125073262 | 12507326 | 3 | C | AMOXYCILLIN | AMOXICILLIN | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 125073262 | 12507326 | 4 | C | AMOXYCILLIN | AMOXICILLIN | 1 | Oral | 500 MG, TID | 0 | 500 | MG | TID | |||||||
| 125073262 | 12507326 | 5 | C | CAPECITABINE. | CAPECITABINE | 1 | Oral | 1500 MG, BID | U | 0 | 1500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125073262 | 12507326 | 1 | Breast cancer |
| 125073262 | 12507326 | 2 | Breast cancer |
| 125073262 | 12507326 | 3 | Osteonecrosis of jaw |
| 125073262 | 12507326 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125073262 | 12507326 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125073262 | 12507326 | Gait disturbance | |
| 125073262 | 12507326 | Limb discomfort | |
| 125073262 | 12507326 | Oedema peripheral | |
| 125073262 | 12507326 | Pain in extremity | |
| 125073262 | 12507326 | Weight increased | |
| 125073262 | 12507326 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125073262 | 12507326 | 1 | 20160502 | 0 | ||
| 125073262 | 12507326 | 2 | 20160502 | 0 | ||
| 125073262 | 12507326 | 5 | 20160601 | 0 |