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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123800502 | 12380050 | 2 | F | 20160415 | 20160712 | 20160518 | 20160718 | PER | PHEH2016US012283 | NOVARTIS | 59.79 | YR | F | Y | 0.00000 | 20160719 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123800502 | 12380050 | 1 | PS | GLEEVEC | IMATINIB MESYLATE | 1 | Oral | 400 MG, QD | 21588 | 400 | MG | TABLET | QD | ||||||
| 123800502 | 12380050 | 2 | SS | GLEEVEC | IMATINIB MESYLATE | 1 | Oral | 200 MG, QD | 21588 | 200 | MG | TABLET | QD | ||||||
| 123800502 | 12380050 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123800502 | 12380050 | 1 | Gastrointestinal stromal tumour |
| 123800502 | 12380050 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123800502 | 12380050 | Constipation | |
| 123800502 | 12380050 | Eye oedema | |
| 123800502 | 12380050 | Fatigue | |
| 123800502 | 12380050 | Joint swelling | |
| 123800502 | 12380050 | Nausea | |
| 123800502 | 12380050 | Oedema | |
| 123800502 | 12380050 | Oedema peripheral | |
| 123800502 | 12380050 | Pain | |
| 123800502 | 12380050 | 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 |
|---|---|---|---|---|---|---|
| 123800502 | 12380050 | 1 | 20160412 | 0 | ||
| 123800502 | 12380050 | 2 | 20160512 | 0 |