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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124560355 | 12456035 | 5 | F | 20160912 | 20160610 | 20160916 | PER | PHEH2016US014327 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160916 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124560355 | 12456035 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 5 DF, QD | D | 5ZP1656 | 22059 | 5 | DF | TABLET | QD | ||||
| 124560355 | 12456035 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | D | 0 | TABLET | |||||||||
| 124560355 | 12456035 | 3 | C | CAPECITABINE. | CAPECITABINE | 1 | Unknown | D | 0 | TABLET | |||||||||
| 124560355 | 12456035 | 4 | C | HYDROCHLOROTH | HYDROCHLOROTHIAZIDE | 1 | Unknown | D | 0 | TABLET | |||||||||
| 124560355 | 12456035 | 5 | C | MORPHINE SULF | MORPHINE SULFATE | 1 | Unknown | D | 0 | EXTENDED RELEASE CAPSULES | |||||||||
| 124560355 | 12456035 | 6 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | UNK ODT | D | 0 | TABLET | ||||||||
| 124560355 | 12456035 | 7 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | UNK | D | 0 | TABLET | ||||||||
| 124560355 | 12456035 | 8 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | Unknown | D | 0 | TABLET | |||||||||
| 124560355 | 12456035 | 9 | C | POTCL | 2 | Unknown | D | 0 | EXTENDED RELEASE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124560355 | 12456035 | 1 | Breast cancer metastatic |
| 124560355 | 12456035 | 2 | Product used for unknown indication |
| 124560355 | 12456035 | 3 | Product used for unknown indication |
| 124560355 | 12456035 | 4 | Product used for unknown indication |
| 124560355 | 12456035 | 5 | Product used for unknown indication |
| 124560355 | 12456035 | 6 | Product used for unknown indication |
| 124560355 | 12456035 | 7 | Product used for unknown indication |
| 124560355 | 12456035 | 8 | Product used for unknown indication |
| 124560355 | 12456035 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124560355 | 12456035 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124560355 | 12456035 | Breast cancer metastatic | |
| 124560355 | 12456035 | Decreased appetite | |
| 124560355 | 12456035 | Diarrhoea | |
| 124560355 | 12456035 | Fatigue | |
| 124560355 | 12456035 | Malaise | |
| 124560355 | 12456035 | Malignant neoplasm progression | |
| 124560355 | 12456035 | Memory impairment | |
| 124560355 | 12456035 | Nausea | |
| 124560355 | 12456035 | Therapy non-responder | |
| 124560355 | 12456035 | Weight 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 |
|---|---|---|---|---|---|---|
| 124560355 | 12456035 | 1 | 20151202 | 20160627 | 0 |