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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120778786 | 12077878 | 6 | F | 20160129 | 20160705 | 20160215 | 20160708 | EXP | PHHY2016CO019973 | NOVARTIS | 78.82 | YR | F | Y | 48.00000 | KG | 20160708 | CN | COUNTRY NOT SPECIFIED | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120778786 | 12077878 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 22334 | 5 | MG | TABLET | QD | ||||||
| 120778786 | 12077878 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 22334 | 5 | MG | TABLET | QD | ||||||
| 120778786 | 12077878 | 3 | C | EXEMESTANE. | EXEMESTANE | 1 | Oral | 25 MG, QD | 0 | 25 | MG | TABLET | QD | ||||||
| 120778786 | 12077878 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 120778786 | 12077878 | 5 | C | OXYCODONE | OXYCODONE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | TABLET | QD | ||||||
| 120778786 | 12077878 | 6 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK OT, QD | 0 | QD | |||||||||
| 120778786 | 12077878 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 120778786 | 12077878 | 8 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 120778786 | 12077878 | 9 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 500 MG, BID | 0 | 500 | MG | TABLET | BID | ||||||
| 120778786 | 12077878 | 10 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | UNK DF, QD | 0 | TABLET | QD | ||||||||
| 120778786 | 12077878 | 11 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 10 MG, PRN (AS NEEDED) | 0 | 10 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120778786 | 12077878 | 1 | Breast cancer metastatic |
| 120778786 | 12077878 | 3 | Breast cancer |
| 120778786 | 12077878 | 4 | Rheumatoid arthritis |
| 120778786 | 12077878 | 5 | Pain |
| 120778786 | 12077878 | 6 | Sleep disorder |
| 120778786 | 12077878 | 7 | Gastritis |
| 120778786 | 12077878 | 8 | Product used for unknown indication |
| 120778786 | 12077878 | 9 | Pain |
| 120778786 | 12077878 | 10 | Gastritis |
| 120778786 | 12077878 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120778786 | 12077878 | HO |
| 120778786 | 12077878 | OT |
| 120778786 | 12077878 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120778786 | 12077878 | Bone pain | |
| 120778786 | 12077878 | Cough | |
| 120778786 | 12077878 | Drug intolerance | |
| 120778786 | 12077878 | Dysphonia | |
| 120778786 | 12077878 | Feeding disorder | |
| 120778786 | 12077878 | Food intolerance | |
| 120778786 | 12077878 | General physical health deterioration | |
| 120778786 | 12077878 | Hypokinesia | |
| 120778786 | 12077878 | Pleural effusion | |
| 120778786 | 12077878 | Terminal state | |
| 120778786 | 12077878 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120778786 | 12077878 | 1 | 20150330 | 0 | ||
| 120778786 | 12077878 | 2 | 20160516 | 0 |