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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114491147 | 11449114 | 7 | F | 20160707 | 20150902 | 20160713 | EXP | PHHY2015CA102056 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160713 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114491147 | 11449114 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 114491147 | 11449114 | 2 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 114491147 | 11449114 | 3 | C | CALCIUM | CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 114491147 | 11449114 | 4 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114491147 | 11449114 | 1 | Chronic myeloid leukaemia |
| 114491147 | 11449114 | 2 | Product used for unknown indication |
| 114491147 | 11449114 | 3 | Product used for unknown indication |
| 114491147 | 11449114 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114491147 | 11449114 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114491147 | 11449114 | Anaemia | |
| 114491147 | 11449114 | Asthenia | |
| 114491147 | 11449114 | Bowel movement irregularity | |
| 114491147 | 11449114 | Constipation | |
| 114491147 | 11449114 | Dizziness | |
| 114491147 | 11449114 | Fatigue | |
| 114491147 | 11449114 | Headache | |
| 114491147 | 11449114 | Hypertension | |
| 114491147 | 11449114 | Muscle spasms | |
| 114491147 | 11449114 | Myalgia | |
| 114491147 | 11449114 | Nausea | |
| 114491147 | 11449114 | Rash | |
| 114491147 | 11449114 | Renal cancer | |
| 114491147 | 11449114 | Renal cyst | |
| 114491147 | 11449114 | Scab | |
| 114491147 | 11449114 | Second primary malignancy | |
| 114491147 | 11449114 | Skin disorder | |
| 114491147 | 11449114 | Vertigo | |
| 114491147 | 11449114 | 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 |
|---|---|---|---|---|---|---|
| 114491147 | 11449114 | 1 | 20150716 | 0 |